What's the difference between supplier responsibilities for Class 2 510(k) & Class 3 PMA products?

[@levipope2555]

Enjoyed the Live Rob.

[@MedicalDeviceAcademy]

I aim to delight, but it is only quality and regulatory.

[@assassinsylvia8117]

Thank you for all the wonderful informative videos! I look forward to seeing next weeks live.

[@MedicalDeviceAcademy]

You are so welcome! Next week's live-streaming video topic is "Where do I start with software and cybersecurity documentation?" We also have a really cool webinar coming upon on the FDA's new QMSR. That's on February 16, 2024. medicaldeviceacademy.com/21-cfr-820/ If you register, you get a copy of our new quality plan template, and we used implementation of the new QMSR as the example.

[@Ken-ch3he]

Thank you for your video. My questions is: My company is an electronic contract manufacturer. We assemble PCB assemblies and are 13485 certified. We have a potential new customer asking for us to quote on their 13485 class 3 medical device (non-invasive). I have asked for quality flow downs and they don't seem to understand my questions. Because they have told us it is a class 3 medical device does that mean we just treat it a class 3 on our end? and what about the traceability level they don't seem to know.... I guess my question is should I be asking them for a specific document or documents to cover us and build the product with the correct QC requirements in place?

[@MedicalDeviceAcademy]

When a customer says a product is "Class 3," you want to make sure it is Class 3 in the USA or some other market. Canada has Class 4, EU and Class IIb and Class III, and the classifications change sometimes when you switch markets. You also need to step back and ask the client basic questions: 1. Do you have a design controls procedure? 2. Do you have a design plan? 3. Do you have design inputs approved? 4. Have you had a pre-sub? Many clients we work with for high-risk devices are relying upon our expertise to tell them what the design inputs are and to help them with a pre-sub. Your potential customer may just be too early in the design process to provide them with a quote. Maybe a project with smaller scope to create those documents you need is what should be quoted.