Expert guidance to bring your medical devices to the market
Navigating the complex landscape of medical device regulations requires expertise, precision, and a clear strategy. RegYOU Consulting offers a comprehensive range of services designed to support your organization at every stage of the regulatory process, ensuring compliance and facilitating the successful market placement and maintenance of your products :
Regulatory Strategy : Providing tailored regulatory strategies to help you navigate the evolving regulatory landscape by analysing and interpreting the relevant regulations such as the EU Medical Device Regulation (MDR), EU In vitro Medical Device Regulation (IVDR) or other regional regulations/standards. From initial planning to final execution, ensuring your approach aligns with applicable legislation and streamlines the pathway to market (including registration requirements).
Regulatory Guidance : Through proactive guidance of the regulations and standards, helping you to adapt to new requirements, interpret their implications for your business, reducing the risk of non-compliance and empowering your organization to respond effectively to regulatory developments.
Design and Development Process : With a focus on regulatory compliance, a guidance in your design and development processes to meet product standards (including risk management), support product changes, building design history file and aligning with the general regulatory requirements, ensuring your product’s readiness for market approval.
Clinical Evaluation : Clinical evidence is the cornerstone of regulatory approval. Brainstorming on the clinical evaluation plan early in process and writing or supporting your clinical evaluation report, for demonstrating the safety and performance of your medical devices.
Technical Documentation : Clear, compliant, and well-structured technical documentation is vital for regulatory approval. Helping you with the creation, review, and maintenance of comprehensive technical documentation that meets the stringent requirements of the medical device regulations. Providing guidance and assistance during the audits of technical documentation review by your Notified Body/Agency.
Post-Market Surveillance (PMS) : Compliance doesn’t end after market entry. Supporting your post-market surveillance activities (including post-market clinical follow-up), ensuring continuous compliance, monitoring product performance, and proactively identifying potential risks to maintain patient safety and regulatory adherence.
Training and supporting internal teams : Investing in training for your internal teams is essential for learning and maintaining regulatory compliance and ensuring product safety.
Person Responsible for Regulatory Compliance (PRRC) : As an experienced professional, serving as your Person Responsible for Regulatory Compliance (only for micro and small enterprises), to fulfill this critical role under the EU MDR/IVDR.
Strategic and pragmatic approach for navigating complex requirements and achieving your goals
With the above services, RegYOU Consulting is committed to helping your organization to achieve regulatory excellence, ensuring your products meet the highest standards while supporting your broader business objectives. Together, we can navigate the complexities of compliance with confidence. Let’s ensure your success in achieving compliance and delivering impactful innovations and learnings to the medical device industry.
