Effective Design Control for Medical Device (21 CFR, Part 820.30)

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All industry professionals, regardless of functional roles, will benefit from this training, especially if you are involved in the day-to-day activities associated with your organization’s design and development process and/or sits on design and development teams.

The effective application of design control is one of the fundamental requirements needed in the design and development of medical devices that are safe and effective in their intended use. Additionally, the lack of effective design controls is one of the more frequently cited violations of the FDA’s Quality System Regulation. Not only is design control needed to support new product development, compliance with §820.30 is mandated by federal regulation.

Not only is an effective approach to design control mandated by regulatory requirements and necessary for the introduction of medical devices that are safe and effective into commerce; data collected during design and development will be needed to support regulatory submissions. Additionally, the FDA will visit your organization’s approach to design control, including the DHF and DMR during an agency inspection.

Areas to be Covered:

Effective Design and development planning
Clearly defining design inputs and outputs
The design review process
Design verification versus design validation
When does the design transfer
Design changes pre & post-design transfer
Maintenance of the Design History File (DHF)
The Device Master Record (DMR)

Who will Benefit:

Quality Professionals
Regulatory Professionals
Design Engineers
Manufacturing Engineers
Project Managers

Dr. Christopher Joseph Devine is the president and founder of Devine Guidance International, Inc., (DGII) a consulting firm providing regulatory and quality compliance support for the medical device industry. Prior to launching DGII, Dr. D spent 14-years with Boston Scientific Corporation working in a variety of quality and regulatory management roles. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on quality and regulatory compliance issues facing the medical device industry; and published by the Medical Device Summit, an e-magazine.

Furthermore, Dr. Devine has 35-years of combined experience in the fields of quality assurance and regulatory affairs; and is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Society of Manufacturing Engineers (SME), and a member of the Project Management Institute (PMI).

Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study. Finally, Dr. Devine is the author of five books on quality and regulatory compliance.

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