4 medical device manufacturing best practices for a successful design transfer (Approve phase)

How can I prepare my QMS to approve my medical device for manufacturing from a design transfer? Learn the key quality processes to establish in your QMS in the final stage of product development and how this proven approach will prepare your QMS for a successful product launch.

This video covers the Approve phase of our S.M.A.R.T methodology, providing a comprehensive overview of how your QMS should be set up and functioning to assist with a successful design transfer so that you can begin the manufacturing of your medical device.

We’ll give you helpful tips to improve the overall health of your QMS, as well as pitfalls to avoid that could hinder your progress.

This video covers the Approve phase of the S.M.A.R.T methodology, which will focus primarily on preparing your QMS to approve the design transfer of your medical device to manufacturing.

Since there's a lot of moving parts by this stage, we'll review all of the key quality processes you should have established in your QMS by the Approve phase, which include:
Training
Purchasing
Device History Record (DHR)
Device Master Records (DMR)
Production and Process Controls
Labeling and Packaging
Receiving, Incoming, In-process and Final Inspections
Identification and Traceability
Change Management
Non-Conforming Materials
CAPA
Management Responsibility

We'll also introduce a set of new processes you'll need to establish in your quality system to be able to complete your design transfer and approve your medical device for manufacturing.

We recommend following these 4 best practices during the Approve-phase in order to properly manage all quality processes that have been implemented through this point leading up to manufacturing:
1) Strive to be in a position to start selling your product the day your device receives market clearance or approval.
2) Assemble a distribution team to help with the actual selling process. This group can often provide marketing support and help organize other events, such as conference exhibits and product training courses.
3) Implement the world-class QMS processes we’ve laid out thus far
4) Use and follow the ‘Refuse to Accept’ checklist guidance from the FDA. Make sure to review this document thoroughly.

We'll help you avoid mistakes that often cause delays during this phase by addressing common myths and setting the records straight once and for all.

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