Design Controls

Roadmap to ISO Certification:  

Design Controls – FX Audio Conference –Recording

%name Design ControlsDesign controls are one of the more difficult concepts for any company to master. For manufacturers that design their own products, the key to mastering design controls is to use a simple process and develop forms that are intuitive for design team members to complete.

The design control requirements include seven sub-clauses in ISO 13485, and these sections are nearly identical to the US FDA’s Quality System Regulations in 21 CFR 820.30. The seven sections also are written in the sequential order your design team should be following.

In this audio conference presentation attendees learn how to manage your design team meetings. The presenter shares examples of common mistakes made by beginners and experts alike. These examples also include solutions developed by the best design teams along with the reasons why each tool will make your job easier. Attendees also learn what information is needed for each step of the design process in order to prepare a Design History File that will withstand even the toughest FDA inspectors and Notified Body auditors.

The Design Controls audio conference covers:

  • Overview of the design controls process (the “Waterfall Diagram”)
  • The best time to implement design controls
  • Explanation of the IOVV Matrix or design requirements matrix (DRM)
  • How to document design changes prior to design transfer
  • What a “design freeze” is and when it should occur
  • Design control records needed for initial ISO 13485 certification
  • Attendees will have the opportunity to purchase a separate breakout session after the conference

About the speaker:

Robert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a Lead Auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions.

Who should attend?

  • Quality Assurance
  • Research & Development
  • Medical Device Design Teams

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Discounted Cost & Registration: Normally FX Conferences charges $259.00 but with the Medical Device Academy special discount you pay $209.00 (you can also get transcripts & recordings & other options). When checking out use the $50.00 discount code fxtpc13.


Other events in the Roadmap to ISO 13485 Certification series:

How to get ISO 13485 Certif 267x300 Design Controls%name Design Controls

Plus – Roadmap to ISO 13485 Certification – The Series – Break Out Sessions

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After each presentation, the speakers will be hosting optional online break-out sessions to facilitate further discussion and to answer company-specific questions. Further details regarding these sessions will be provided to registrants along with the presentation materials for each event.


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