The rapid advancement of technology in the medical device industry has dramatically transformed healthcare delivery while introducing new challenges for regulatory frameworks worldwide. This comprehensive analysis explores how technological innovation is reshaping regulatory requirements and what it means for medical device manufacturers and healthcare providers. The Evolution of Medical Device Regulations in the Digital Era The emergence of SaMD (Software as Medical Device – Software como Dispositivo Médico) and connected health technologies has prompted regulatory bodies such as ANVISA (Brazilian Health Regulatory Agency), FDA (Food and Drug Administration), and other global health product authorities to adapt their approaches. These innovations introduce new considerations for patient safety, data security, and product effectiveness that were not relevant under traditional medical device regulations. Key Regulatory Changes Driven by Innovation Software and AI-Based Medical Devices Recent regulatory updates, such as RDC 751/2022 in Brazil, reflect the increasing need to address software-based medical devices specifically. These regulations now include provisions for: ✅ Continuous monitoring and updates for software-based devices ✅ Risk assessment frameworks for AI (Artificial Intelligence) and ML (Machine Learning) applications ✅ Cybersecurity requirements and data protection measures ✅ Validation procedures for algorithm updates Connected Medical Devices The integration of IoT (Internet of Things) capabilities into medical devices has led to new regulatory requirements related to: ✅ Interoperability standards for medical devices ✅ Remote monitoring capabilities ✅ Secure data transmission protocols ✅ Real-time performance tracking Impact on Quality Management Systems The evolution of medical device technology has significantly influenced GMP (Good Manufacturing Practices) requirements and MDSAP (Medical Device Single Audit Program) implementations. Modern quality management systems must now consider: ✅ Lifecycle management of software development ✅ Continuous improvement processes for digital solutions ✅ Risk management for connected devices ✅ Documentation requirements for software updates Case Studies: Challenges and Solutions in Regulating Innovative Technologies Artificial Intelligence and Machine Learning in Medical Devices 📌 Case Study: Diabetic Retinopathy Detection System An AI-powered system designed to detect diabetic retinopathy through retinal image analysis faced significant regulatory challenges during approval. The primary obstacle was proving the reliability of the machine learning algorithm and its ability to adapt over time. Regulatory Challenge: ANVISA and FDA require continuous validation of the algorithm’s performance, especially after software updates that may impact diagnostic accuracy. Software as a Medical Device (SaMD) 📌 Case Study: Cardiac Arrhythmia Monitoring App A mobile app that uses a smartphone sensor to detect cardiac arrhythmias had to navigate complex regulatory requirements across different jurisdictions. Regulatory Challenge: Determining the appropriate risk classification and establishing clinical validation protocols that comply with RDC 751/2022 in Brazil and similar international regulations. IoT Devices and Wearables 📌 Case Study: Continuous Glucose Monitoring (CGM) System A CGM system with Bluetooth connectivity and real-time data transmission to healthcare professionals faced challenges related to cybersecurity and data protection. Regulatory Challenge: Ensuring compliance with both medical device regulations and data protection laws, such as LGPD (Brazilian General Data Protection Law). 5 Practical Tips to Overcome Regulatory Challenges in Innovative Technologies 1. Early Regulatory Planning 📌 Case Study: A smartwatch manufacturer with ECG functionality saved 8 months in the approval process by: 🔹 Engaging with ANVISA early before final product development 🔹 Aligning clinical study designs with regulatory requirements 🔹 Preparing technical documentation in parallel with product development 2. Implementing a Robust Change Management System 📌 Case Study: A SaMD company specializing in medical imaging diagnosis established: 🔹 A detailed version control process 🔹 Validation protocols for algorithm updates 🔹 A traceability system for software modifications 🔹 Comprehensive documentation for software development lifecycle 3. Comprehensive Clinical Validation Strategy 📌 Case Study: A wearable blood pressure monitor obtained faster approval by: 🔹 Conducting clinical studies across multiple populations 🔹 Implementing validation protocols for different use conditions 🔹 Establishing comparisons with gold-standard methods 4. Effective Post-Market Surveillance Program 📌 Case Study: An AI-powered skin cancer screening system implemented: 🔹 Real-time performance monitoring 🔹 Continuous accuracy analysis 🔹 Update protocols based on real-world evidence 🔹 Proactive adverse event reporting system 5. Integrated Cybersecurity Approach 📌 Case Study: A continuous glucose monitor with IoT connectivity secured approval by demonstrating: 🔹 End-to-end data encryption for patient information 🔹 Multi-factor authentication protocols 🔹 Incident response plan for security breaches 🔹 Regular cybersecurity updates Regulatory Compliance Strategies for Innovative Devices Documentation and Technical Requirements Companies must adapt their regulatory submission strategies to address: ✅ Enhanced Instructions for Use (IFUs) for complex technological features ✅ Validation of laboratory-developed tests ✅ Verification and validation procedures for software ✅ Cybersecurity risk assessments Market Access Considerations Successfully navigating the regulatory landscape requires: ✅ Early engagement with regulatory authorities ✅ Understanding market-specific requirements ✅ Developing a comprehensive regulatory strategy ✅ Regular monitoring of regulatory updates via resources like the Radar Newsletter Future Trends and Preparations Emerging Technologies The regulatory landscape continues to evolve with: ✅ AI/ML applications in healthcare ✅ Digital therapeutics ✅ Remote monitoring solutions ✅ Personalized medicine technologies Regulatory Harmonization Global initiatives are working towards: ✅ Standardized regulatory approaches for software ✅ International recognition of quality management systems ✅ Unified device identification systems ✅ Streamlined approval processes Conclusion As technological innovation accelerates, regulatory frameworks must balance patient safety with fostering innovation. Companies must stay informed about regulatory changes while ensuring compliance with current requirements. Success in this dynamic environment requires a proactive regulatory strategy and a commitment to quality management through: ✅ Deep understanding of evolving regulatory requirements ✅ Implementation of robust quality systems ✅ Well-planned clinical validation strategies ✅ Continuous monitoring of performance and security Companies that adopt a proactive and integrated approach to regulatory compliance are better positioned to: ✅ Reduce approval timelines ✅ Minimize development costs ✅ Maintain continuous compliance ✅ Ensure sustainable commercial success For expert guidance on navigating complex regulatory requirements, contact our medical device regulatory consulting team to ensure your innovative products meet all compliance standards while maintaining a competitive edge in the market. 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How to Obtain ISO 13485 Certification for Medical Devices: A Comprehensive Guide
In today’s highly regulated medical device industry, obtaining ISO 13485 certification is crucial for manufacturers looking to demonstrate their commitment to quality and regulatory compliance. This comprehensive guide will walk you through the essential steps and requirements for achieving this vital certification. Understanding ISO 13485 and Its Importance ISO 13485 is an internationally recognized standard that establishes requirements for a quality management system (QMS) specific to the medical device industry. This certification is particularly important for manufacturers seeking to enter global markets and comply with various regulatory requirements, including those established by health products regulatory authorities worldwide. Key Requirements for ISO 13485 Certification 1. Quality Management System Development The foundation of ISO 13485 certification lies in establishing a robust QMS that addresses: 2. Risk Management Integration A critical component of ISO 13485 is the integration of risk management throughout the product lifecycle. This includes: 3. Design and Development Controls Medical device manufacturers must implement comprehensive design controls that include: 4. Production and Process Controls Establishing effective production controls involves: Steps to Obtain ISO 13485 Certification 1. Gap Analysis and Preparation 2. Documentation Development 3. Implementation 4. Certification Audit Maintaining ISO 13485 Certification Maintaining certification requires: Benefits of ISO 13485 Certification Key Challenges and Practical Solutions Top 10 Challenges in ISO 13485 Certification 5 Essential Tips to Overcome Challenges Conclusion Obtaining ISO 13485 certification is a significant achievement that demonstrates your organization’s commitment to quality and regulatory compliance in the medical device industry. While the process requires substantial resources and dedication, the benefits far outweigh the investment, particularly for companies seeking to expand their global presence and maintain a competitive edge in the medical device market. For assistance with your ISO 13485 certification journey or to learn more about medical device regulatory requirements, contact our expert consultants who specialize in medical device consulting and regulatory compliance. Find out more about BPO in RA! *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
Challenges in International Medical Device Registration: Market Comparison
In today’s globalized healthcare market, navigating the complex landscape of international medical device registration presents significant challenges for manufacturers and regulatory professionals. This comprehensive analysis examines the key differences and challenges between major markets, providing insights for successful market entry strategies. Understanding Regional Regulatory Authorities The global regulatory landscape for medical devices is characterized by different classification systems and specific requirements in each market. The main markets—ANVISA, FDA, and MDR (Europe)—show significant variations in their approaches to device classification and registration, which can directly impact market entry strategies. For a detailed analysis of the classification system differences between ANVISA, FDA, and MDR, including specific rules and practical impacts, we recommend reading our full article on the blog: Comparative Classification of ANVISA, FDA, and MDR: Key Differences Explained. Key Challenges in Global Registration Documentation Requirements One of the most significant challenges lies in preparing and maintaining proper documentation across different markets, including: Market-Specific Considerations Brazil’s regulatory environment, centralized under ANVISA in Brasília, presents unique challenges: Quality Management Systems Different markets have varied requirements for quality management systems: Strategic Approaches for Success Unified Documentation Strategy Developing a comprehensive documentation approach that meets multiple regulatory bodies’ requirements simultaneously can significantly streamline the registration process. This includes: Professional Support and Resources Successful navigation often requires: Future Trends and Considerations The regulatory landscape continues to evolve, with increasing focus on: Conclusion and Strategic Recommendations To achieve success in international medical device registration, we recommend implementing the following specific strategies: Regulatory Process Optimization Time and Resource Management Cost and Risk Reduction Best Practices for Submission Implementing these strategies can significantly reduce approval time, minimize costs, and increase success rates in international regulatory submissions. For personalized support with your regulatory strategy or more information on optimizing your international registration process, contact our team of experts. Find out more about BPO in RA! *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
Understanding the Regulatory Framework for Medical Devices in Brazil
The Brazilian medical device market, one of the largest in Latin America, offers significant opportunities for international manufacturers. However, success in this market requires an in-depth understanding of the regulatory landscape, overseen by ANVISA (National Health Surveillance Agency). The Brazilian regulatory framework for medical devices is based on several key resolutions (RDCs). RDC 185/2001 establishes the fundamental requirements for medical device registration, while more recent regulations, such as RDC 751/2022 and RDC 665/2022,, have introduced important updates to the regulatory framework. ANVISA places great emphasis on Good Manufacturing Practices (GMP) certification. International manufacturers must demonstrate compliance with Brazilian GMP requirements, which align with international standards but also include country-specific elements. The certification process typically involves: Device Risk Classification Overview of the Registration Process The registration process for medical devices in Brazil involves several key steps: Considerations for Software as a Medical Device (SaMD) With the rise of digital health solutions, ANVISA has developed specific requirements for Software as a Medical Device (SaMD). These products require specialized documentation and risk evaluation approaches, focusing on: Laboratory-Developed Tests and In Vitro Diagnostics The regulation of Laboratory-Developed Tests has gained increasing importance in the Brazilian healthcare system. Manufacturers must meet specific requirements, ensuring compliance with international standards and local market demands. Market Access Strategies Success in entering the market requires more than regulatory compliance. Companies should consider: Working with Regulatory Specialists Given the complexity of the Brazilian regulatory environment, many international companies choose to work with specialized medical device consultancies. These partnerships can provide: Conclusion Navigating Brazil’s medical device regulatory framework requires careful planning, thorough understanding, and often local expertise. While the process can be complex, the potential rewards of accessing one of Latin America’s largest healthcare markets make it a worthwhile endeavor for many international manufacturers. For companies seeking to enter or expand in the Brazilian market, working with experienced regulatory partners can significantly streamline the process and improve chances of success. These partners can provide crucial insights into both regulatory requirements and market access strategies, ensuring a more efficient path to market. Contact our regulatory experts to discuss your specific needs and develop a tailored strategy for your medical device registration in Brazil. Find out more about BPO in RA! *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
Understanding Medical Device Classification in Brazil: A Comprehensive Guide to ANVISA Requirements
Are you a medical device executive looking to understand how medical devices are classified in Brazil? This comprehensive guide will walk you through ANVISA’s classification system and requirements, helping you navigate the Brazilian regulatory landscape effectively. The Brazilian Regulatory Framework Brazil’s medical device market, regulated by ANVISA (Brazilian Health Regulatory Agency), operates under specific guidelines that ensure product safety and efficacy. Understanding these classifications is crucial for successful market entry and regulatory compliance. Risk Classification System ANVISA’s medical device classification follows both risk categories and specific classification rules as defined in RDC 751/2022: Class I (Low Risk) Class II (Medium Risk) Class III (High Risk) Class IV (Maximum Risk) Classification Rules Structure The 22 classification rules are organized into four main categories: Note: Detailed classification rules can be found in Annex I of RDC 751/2022. Analysis timeframes are estimates and may vary based on ANVISA’s current workload. GMP Requirements and MDSAP Considerations For higher-risk devices (Classes III and IV), manufacturers must demonstrate compliance with Good Manufacturing Practices (GMP). Brazil participates in the Medical Device Single Audit Program (MDSAP), which can streamline the certification process for international manufacturers. To learn more about this topic, click here. Software as a Medical Device (SaMD) With the increasing prevalence of digital health solutions, ANVISA has specific requirements for Software as a Medical Device (SaMD). These products must undergo classification and registration based on their intended use and potential risk. Laboratory Developed Tests Considerations For manufacturers dealing with laboratory developed tests, additional requirements apply under specific ANVISA regulations. These products require special attention to classification and validation requirements. Registration Process and Documentation The registration process varies by classification: Market Access Strategy Successful market entry requires: For expert guidance on medical device registration and regulatory compliance in Brazil, contact Brisa Advisors for specialized regulatory support. Find out more about BPO in RA! *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
ANVISA’s Role in Medical Device Regulation: Structure and Impact on Brazil’s Healthcare Market
Medical device manufacturers seeking to enter the Brazilian market must navigate a complex regulatory landscape overseen by ANVISA (Agência Nacional de Vigilância Sanitária) in Brasilia. Understanding this regulatory framework is crucial for successful market access and compliance in Latin America’s largest healthcare market. Regulatory Framework and Authority ANVISA, established by Law No. 9,782 in 1999, operates as an independent regulatory agency under the Ministry of Health. The agency’s primary mission encompasses protecting public health through comprehensive regulation of medical devices and other healthcare products. This regulatory oversight includes several key areas: Registration and Classification System Medical devices in Brazil must undergo a thorough registration process based on their risk classification (Classes I through IV). This process is governed by various regulatory directives (RDCs), including: Good Manufacturing Practices (GMP) ANVISA requires manufacturers to maintain strict adherence to Good Manufacturing Practice (GMP) standards, which align with international requirements like ISO 13485. This certification process includes: Software as a Medical Device (SaMD) With the increasing prevalence of digital health solutions, ANVISA has developed specific regulations for Software as a Medical Device (SaMD). These requirements include: Market Access Considerations For international manufacturers, working with experienced medical device consulting firms can significantly streamline the registration process. Key considerations include: Laboratory Developed Tests and IFUs The regulation of Laboratory Developed Tests requires specific attention to: Medical Device Unique Device Identification(UDI) ANVISA’s implementation of UDI requirements aligns with global standards and includes: International Harmonization ANVISA actively participates in international regulatory harmonization efforts, including: MDSAP Participation The Medical Device Single Audit Program (MDSAP) acceptance demonstrates ANVISA’s commitment to: Health Sciences Authority Collaboration ANVISA maintains partnerships with various international regulatory bodies, including: Contact and Support For manufacturers seeking regulatory support in Brazil, maintaining direct contact with ANVISA through official channels is essential. The agency provides various support mechanisms: Conclusion Successfully navigating ANVISA’s regulatory requirements demands a comprehensive understanding of both technical and procedural aspects. International manufacturers should consider partnering with experienced regulatory consultants to ensure compliance and optimize their market access strategy in Brazil. For expert guidance on medical device registration and regulatory compliance in Brazil,, contact Brisa Advisors for specialized regulatory support. Find out more about BPO in RA! *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
Ensuring Patient Safety: The Critical Importance of Medical Device Registration
In today’s modern healthcare landscape, medical devices play a pivotal role in patient care, diagnostics, and treatment. However, bringing these devices to market requires navigating complex regulatory frameworks designed to ensure patient safety and product efficacy. Understanding the intricacies of medical device registration is crucial for manufacturers looking to enter new markets while maintaining compliance with regulatory requirements. The Foundation of Medical Device Safety The journey of a medical device from development to market involves rigorous regulatory oversight. Health products regulatory authorities worldwide, including ANVISA in Brazil, the FDA in the United States, and other prominent health sciences authorities, have established comprehensive frameworks to evaluate and monitor medical devices. These frameworks serve as gatekeepers, ensuring that only safe and effective devices reach healthcare providers and patients. Key Components of Medical Device Registration GMP Compliance and Quality Management Good Manufacturing Practice (GMP) certification stands as a cornerstone of medical device registration. Manufacturers must demonstrate robust quality management systems that align with international standards. This includes: Technical Documentation Requirements Successful registration requires comprehensive technical documentation that includes: Regulatory Compliance and Standards In Brazil, manufacturers must navigate specific regulatory requirements, including: MDSAP and International Recognition The Medical Device Single Audit Program (MDSAP) has become increasingly important for manufacturers seeking market access across multiple jurisdictions. This program allows for a single regulatory audit to satisfy the requirements of multiple regulatory authorities, streamlining the compliance process. Critical Considerations for Manufacturers Risk Classification and Documentation Medical devices are categorized based on their risk level, which determines the extent of documentation and testing required for registration. Higher-risk devices typically require: Laboratory Developed Tests For manufacturers dealing with laboratory developed tests, special considerations apply regarding validation, verification, and quality control measures. These requirements ensure the accuracy and reliability of diagnostic results.See more about the step by step by clicking here. Post-Market Surveillance Maintaining registration requires ongoing vigilance through: Unique Device Identification (UDI) Implementation The implementation of UDI systems has become a crucial aspect of medical device registration and traceability. This system helps: Strategic Approach to Registration Market Access Strategy Developing a comprehensive market access strategy involves: Professional Support and Consultation Given the complexity of medical device registration, many manufacturers benefit from: Conclusion Successfully navigating medical device registration requires a thorough understanding of regulatory requirements, quality standards, and market-specific considerations. By prioritizing compliance and maintaining robust quality management systems, manufacturers can ensure their devices meet the necessary safety and efficacy standards while efficiently accessing their target markets. For manufacturers seeking to enter the Brazilian market or expand their presence, understanding ANVISA’s requirements and working with experienced regulatory professionals can significantly streamline the registration process. This investment in proper registration procedures not only ensures regulatory compliance but also builds trust with healthcare providers and patients, ultimately contributing to better healthcare outcomes. For expert guidance on medical device registration and regulatory compliance in Brazil, contact specialized regulatory affairs consultants who can provide comprehensive support throughout the registration process. For expert guidance on medical device registration and regulatory compliance in Brazil,, contact Brisa Advisors for specialized regulatory support. Find out more about BPO in RA! *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
Key Representative Institutions in the Medical Devices Market
The medical devices (MD) sector in Brazil plays a crucial role in public and private healthcare, providing essential technologies for patient diagnosis, treatment, and monitoring. To ensure the sustainable and ethical development of the sector, various representative institutions act as pillars of regulation, innovation, and best practices. This article explores the main associations and organizations shaping the medical devices market in the country. ABIMED: Brazilian Association of the Medical Technology Industry Founded in 1996, ABIMED is one of the leading entities in the sector, representing around 200 companies involved in medical technologies. Its mission includes: ABIMO: Brazilian Association of the Medical Devices Industry ABIMO represents national companies engaged in manufacturing medical, dental, hospital, and laboratory devices. Focusing on promoting domestic industry, the association seeks to: CBDL: Brazilian Chamber of Laboratory Diagnostics CBDL plays a central role in promoting the in vitro diagnostics (IVD) segment, responsible for essential laboratory technologies. Its main initiatives include: ABIIS: Brazilian Alliance of Innovative Health Industry ABIIS brings together associations and companies to promote innovation and sustainability in Brazil’s healthcare system. Its areas of action include: SindHosp: Union of Hospitals, Clinics, and Laboratories of São Paulo Although focused on healthcare institutions, SindHosp also indirectly impacts the medical devices market by representing the interests of hospitals and laboratories that use these technologies. The entity is dedicated to: SBPC/ML: Brazilian Society of Clinical Pathology/Laboratory Medicine SBPC/ML is a reference in the field of laboratory diagnostics and, although a scientific society, its actions directly impact the medical devices market. Its contributions include: ANAHP: National Association of Private Hospitals ANAHP represents private hospitals of excellence in Brazil and, while focused on healthcare institutions, its actions influence the medical devices market by: CMB: Confederation of Charitable Hospitals, Philanthropic Entities, and Mercy Hospitals CMB is one of the largest representative entities for philanthropic hospitals in Brazil, which are significant users of medical devices. The confederation focuses on: ABRAIDI: Brazilian Association of Importers and Distributors of Healthcare Products ABRAIDI plays a crucial role in representing companies that import and distribute medical devices in Brazil. Its initiatives include: The Importance of Collaboration Among Entities The medical devices market is vast and complex, requiring the collaboration of multiple entities to address challenges such as regulation, innovation, access, and sustainability. Representative institutions play complementary roles, working to: Conclusion Strengthening the medical devices market in Brazil depends on joint actions by different representative entities. Each organization, with its expertise and specific focus, contributes to efficient regulation, the promotion of innovation, and the guarantee of a competitive and sustainable environment. Understanding the role of these institutions is essential for professionals, companies, and managers seeking to develop impactful solutions in the healthcare sector. References For any questions, contact Brisa Advisors for specialized regulatory support. Find out more about BPO in RA! *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
RDC 938/2024: A New Chapter for Good Storage Practices
The RDC 938/2024 resolution, published by Anvisa, introduces significant updates to the Good Storage Practices (GSP) for goods and products subject to health surveillance in bonded warehouses. Effective from March 3, 2025, this regulation replaces RDC 346/2002, aiming to enhance safety, quality, and efficiency in the country’s logistics operations. Below, we explore the resolution’s key points, its impacts on the industry, and the necessary steps for compliance. What Does RDC 938/2024 Establish? RDC 938/2024 sets out clear and comprehensive guidelines for the storage of goods and products under health surveillance. It addresses aspects such as Quality Management System (QMS) implementation, infrastructure requirements, documentation, and training. Scope: Objectives: Key Requirements of RDC 938/2024 The resolution introduces significant changes that will require operational adjustments from companies. Below are the highlights: 1. Quality Management System (QMS) Companies must implement a robust QMS to monitor all stages of the storage process. This system should include: 2. Infrastructure and Facilities Warehouses must meet the following specifications: 3. Temperature-Sensitive Products Products sensitive to temperature require special attention. The resolution demands: 4. Qualification and Validation All equipment and computerized systems impacting quality must be qualified or validated. This includes: 5. Documentation and Records The resolution emphasizes strong document management practices: Impacts on Companies Compliance with RDC 938/2024 requires a comprehensive review of operations and investments in infrastructure, technology, and training. Key challenges and opportunities include: Deadlines and Penalties Anvisa has set specific deadlines for company compliance: Non-compliance may result in: How to Prepare? To ensure compliance with RDC 938/2024, companies should: Conclusion RDC 938/2024 represents a significant advancement in the safety and efficiency of Brazil’s logistics sector. While the requirements are demanding, they also present opportunities for companies to enhance their operations and stand out in the market. Adopting Good Storage Practices is not just about compliance—it’s about competitiveness and a commitment to quality. 📝 Access the translated version of RDC 938/22 RDC Nº 938/2024 The original language version of this announcement is the authorized official version. Translations are provided for convenience and should refer to the original language text, which is the only legally binding version. Click the link to access the Original Version For any questions, contact Brisa Advisors for specialized regulatory support. Find out more about BPO in RA! *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
Brisa Advisors at MEDICA 2024: Connecting with the Future of Healthcare
Brisa Advisors made its mark at MEDICA 2024, the world’s largest medical industry event, held from November 11 to 14 in Düsseldorf, Germany. This event showcased the latest advancements in medical devices and innovative technologies, offering an inspiring glimpse into the future of healthcare. More than just exploring the vast exhibition space, we leveraged MEDICA 2024 as a strategic platform to strengthen connections and expand our horizons: These interactions reaffirmed our commitment to excellence and innovation. Armed with the knowledge and connections gained, we are ready to transform these insights into even more impactful solutions for our clients and partners worldwide. Click here to learn more about the event: https://brisa.com.br/brisa-advisors-at-medica-2024-connecting-innovations-to-the-brazilian-medical-device-market/ For any questions, contact Brisa Advisors for specialized regulatory support. Find out more about BPO in RA! *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br