Clinical Trial Design for Medical Devices

Clinical studies are an integral part of the approval process for medical devices. While some devices may be approved with little or no clinical data, for others, manufacturers need to demonstrate, with safety and effectiveness data in the target population, that the product is safe for human use.

This course offers an overview of the regulatory process for medical device applications, including medical device clinical trial design and implementation. Throughout, examples and case studies will help participants apply the concepts being covered.

Glenda Guest is Vice President of Norwich Clinical Research Associates Ltd (NCRA). This full-service clinical CRO in upstate NY consults on study development, monitoring and analysis; clinical and data-management-department development; regulatory consulting; SOP consulting; GCP and clinical regulatory training/auditing services. NCRA has performed a number of FDA mandated third-party audits for companies against which an integrity hold has been applied – an experience that has allowed Ms. Guest to develop a solid understanding of CDRH expectations.

Since 2004 Ms. Guest has lectured and trained on such topics as medical device clinical research, FDA Inspection preparedness, using FDA Warning Letters to improve practices, 21 CFR Part 11 compliance, computerized systems in clinical trials, electronic medical records, the changing 510(k) environment and quality systems in clinical trials.

With 14 years of experience in regulated research involving medical devices and an extensive background in clinical CRO; Ms. Guest has a unique perspective on regulatory requirements for device development and market approval. Serving such medical device companies as Welch Allyn, NMT Medical and BSD Medical; Ms. Guest has worked with large and small manufacturers in both premarket approval and 510(k) realms. Consulting for a global clinical research professional society, she also co-developed a two-day advanced training course for device professionals.

Ms. Guest is a Registered Quality Assurance Professional in Good Clinical Practices through the Society for Quality Assurance.