My experience with design control was with Triangle Manufacturing when I was working as a Quality Engineering co-op. One of my responsibilities was to take part in design meetings and assist the project manager to create BOM (Bill of Materials). I completely agree with the design controls as outlined in this week lecture. Most medical device manufacture companies use the similar design controls except they are named differently.

After we look at the blueprint, we have design review meeting and we identify the key process on how we are going to make that product accurately and efficiently essentially DDP (not called the same thing). Next step is to create a BOM (Bill of Materials) from the approved vendors. Verification and Validation are referenced the same in most medical companies. However, validation was little different in a way as we have to validate all the machines, that the specific product will be manufactured. That includes transferring from one machine to another and also if the same machine (same brand) is in a different building still needs validation. Furthermore, any design changes in mid production has to be noted on a special form which when the product is finished gets put in the DHF (Device History File).

All in all, the nine parts of design controls are very important in medical devices. In my opinion, they should be implemented in all the manufacturing companies as it reduces errors and helps manufacture products efficiently and accurately.