What are Regulatory Affairs for Medical Devices?

Regulatory Affairs (RA) is the discipline responsible for ensuring that medical devices are developed, manufactured, and marketed in accordance with global regulatory requirements. RA professionals act as the link between the company and regulatory authorities, such as the EU Notified Bodies or the US FDA, ensuring that products are safe and effective for their intended use.

Our expert team provides you with strategic guidance on navigating the evolving regulatory landscape, helping you secure the necessary approvals to bring your medical devices to market across multiple regions.

Our Services:

• Regulatory Strategy Development: We craft customized regulatory strategies that align with your product's characteristics and market requirements, ensuring a streamlined approval process.
• Worldwide Regulatory Submissions: We manage regulatory submissions for various regions, including CE Marking, UKCA Marking, FDA 510(k) Premarket Notification, Health Canada Approvals, and other international markets. Our team ensures that all submission documentation is complete, accurate, and compliant with local regulatory bodies.
• Clinical Evaluation Support: We assist with clinical evaluations to meet regulatory standards, providing thorough analysis and clinical evidence to support safety and effectiveness claims such as against ISO 14155.
• Regulatory Compliance & Auditing: We ensure ongoing compliance with international regulations such as MDR (EU Medical Device Regulation), FDA requirements, ISO 13485, MDSAP (Medical Device Single Audit Programme), and other applicable regulations. Our team also conducts audits to confirm that your regulatory practices align with current standards.
• Post-Market Surveillance (PMS): We help establish and manage post-market surveillance systems to monitor product performance, ensure safety, and meet regulatory reporting obligations.
• Risk Management: We help you implement risk management practices in line with ISO 14971, ensuring that your devices are safe throughout their lifecycle.

By partnering with us, you gain a trusted ally to navigate the complexities of medical device regulations, helping your products meet global standards while speeding up market access. We ensure that every aspect of the regulatory process is handled with precision and expertise.