Design Controls for Medical Devices and IVDs

This instructor-led two-day course covers design control principles and design and development regulatory requirements relative to U.S. 21 CFR Part 820, ISO 13485:2016 and the EU MDR. Practical examples will be incorporated.

This course covers important requirements for medical device and IVD design controls. Learners will benefit from open dialogue and the sharing of current design and development processes; highlighting how misperceptions of regulatory requirements have led to less-than-optimal practices. This course also provides guidance for all phases of medical device design and development projects, as well as retrospective gap analysis of design history files to help develop new technical files under the EU MDR and IVDR.

At the end of this training, learners will be able to:

• Identify key regulatory requirements for risk management
  • European Union
  • Quality System Regulation
  • ISO 13485:2016
• Identify key principles of ISO 14971:2019
• Identify key regulatory requirements for design controls:
  • European Union
  • Quality System Regulation
  • ISO 13485:2016
• Recognize potential exemptions from design control requirements
• Identify when, during a design and development project, design control requirements apply
• Conceptualize graphically a design control process

This class is vital for any medical device research and development professional, regulatory scientist and/or clinician involved in developing and manufacturing medical devices. This course provides critical knowledge for both regulatory affairs and quality assurance professionals.

Course tutors selected from the following:

James Pink - James Pink has over 20 years of experience in the medical devices industry including 10 years as a health care technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and non-active implantable and combination products. Mr. Pink is a contributor to several medical device standards committees including ISO 13485, ISO 14971 and various product-related standards.

Janet Book - Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices, she has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations as well as capability assessments. She has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing quality management systems; and developing and presenting quality-related training and seminars. Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in privacy providing guidance on quality, regulatory and compliance functions. She is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and an RABQSA Quality Systems Lead Auditor.