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Medical Device Design Controls: How to Handle, Monitor and Manage

Duration :

Course Description:

This 3-hr webinar will help you understand the basics of medical device design controls and how to initiate, handle, monitor, and manage them. You will also learn the purpose and scope of medical device design controls, best design control practices, the similarities and differences between FDA and Notified Body design control requirements, and what is expected when an external auditing body examines your design control procedures and documentation.

Why should you Attend?

Most industry personnel are overwhelmed by national and international quality system laws, directives, regulations, standards, and guidance documents. As such, they believe if they obtain quality system certification from a European Notified Body that they will automatically pass an FDA audit. However, this is not the case, especially in the area of design controls. FDA warning letter after Warning Letter prove otherwise True that Europe's quality management system standard (ISO 13485) and U.S.A's quality system regulation (21 CFR Part 820) are very similar in nature; however, your design control system is viewed totally different by the FDA than by the European Union. Not only is it required under law to have design control procedures and records, however the FDA requires you to also have a sound design control system with linkages to other QSR subsystems; whereas the Notified Bodies do not. If top management do not initiate an effective design controls system, not only may regulatory compliance sanctions against the company occur, but the company may also loose its competitive advantage, have customer lawsuits, perform unnecessary recalls, and be known as a company with non-quality products and services.

Areas Covered:

This webinar will provide valuable assistance to all medical device companies in developing a sound design control system, and initiating, handling, monitoring managing, and maintaining design controls. The focus will be a basic understanding of quality system design controls without confusing everyone with regulatory compliance jargon. The webinar will include the following:

  • The definition, purpose and scope of design controls;
  • How design controls fit into a quality system;
  • Design control basics;
  • Human Factors;
  • Hazard and Risk Analyses/Management;
  • Change Management;
  • Validation and Verification Activities;
  • 21 CFR Part 820, Design Controls;
  • ISO 13485 Design Controls;
  • The similarities and differences between FDA and Notified Body Design Controls; and
  • The Design Controls subsystem under FDA’s Quality System Inspection Technique (QSIT)

Who will benefit?

This topic applies to personnel / companies in the medical device industry. The employees who will benefit most include:

  • Senior management,
  • Regulatory Affairs, Regulatory Compliance, and Quality Assurance personnel, and
  • Quality, Manufacturing, and Design engineers.

Registration Options


Avail 12 months unlimited access for a single user.


Material shipped within 15 days post webinar completion & get life time access for unlimited participants.



Speaker Details

George Gary  Calafactor

George Gary Calafactor

Mr. Calafactor has over 21 years of FDA / governmental experience also as an analyst and level II certified international medical device investigator and over 7 years of industrial experience as a biologic, pharmaceutical, and medical device industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor. George not only has inspected, investigated, and audited all types of US and foreign food, cosmetic, drug, biologic, medical device, and clinical

Refund Policy



Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@complyarena.com or call +1-888-222-5917 (Toll Free).