Questions to Ask a Prospective Contract Manufacturer for Your Medical DeviceQuestions to Ask a Prospective Contract Manufacturer for Your Medical Device

How are you arriving at my price? Make sure your contract manufacturer uses a cost model and pricing model that is fully transparent so you can see the roll-up costs on a make-versus-buy basis and the margin that your contract manufacturer is applying to arrive at your price.

What is made versus bought? How have they gone about selecting their supply chain partners? What are the qualifications of those partners? How long have those partners been in place?

How can you prove to me that you can make my device successfully? Do they have experience making that device for other customers? What problems or constraints have they been able to work through, and how can they objectively demonstrate that they’ve brought those solutions to prior device launches?

Show me your ISO 1345 certificate. Look for the scope on that certificate that states the scope of services and topics that certificate covers. You want to read that scope carefully and assure that your contract manufacturer has a certificate that covers the scope of your device specifically. Also, look at the notified body on that certificate. Check the level of sophistication and capability of that notified body and assure that it meets with the standards you would expect out of a high-end quality contract manufacturer.

When can I (or my representative) come and audit your quality management system (QMS)? When you go to audit the QMS of your contract manufacturer, don’t just look at the paperwork and the perfunctory audit functions, but also look at how the quality representatives present themselves.

How do you assure traceability and material control?

What processes of continuous improvement do you practice?

How does an operator on the line provide improvement feedback?

Tell me about a time when you had to mitigate a line problem quickly.

How are suppliers qualified? How do you measure their performance?

Show me your RI procedure. Where are bad parts quarantined?

How will you communicate supplier challenges with me?

Are you familiar with the September 2023 cybersecurity guidance?

Is your company ISO 27001 compliant?

What is your strategy for security planning, staffing, and training?

How do you characterize process capability both on the sourced and the made side?

What changes would you make to make it easier/cheaper to make?

Do you have design engineers onsite?

When do you consider automated over manual testing?

Show me an automated test system on your floor. Who built it?

How is your test data stored? How is it traceable?