I have just been tasked to benchmark, see what everyone else is doing, against other "world class" companies in the medical device field governed by FDA and ISO 13485:2003 standards.

We are <100 employee company with 8 engineers, 2 QA and 2 product lines. Softwares usually released every 6 months. Of course we have never made a release date and I spend most a lot of time in verification and validation testing.

We use a 5 tier design control.

1. Concept, Research, and Feasibility
2. Development
3. Design Verification
4. Design Validation and Integration into Operations
5. Commercialzation

each stage having a Exit Review. Unfortunately a lot of time is spent in a "engineering" void and I end up being a development tester rather than conducting design verification. Tier 2 and 3 kind of blend together more than I would like.

I would like to hear from others in my industry to compare notes and see what works and what does not. Even those not in my industry, I would like to hear more concerning how your development process and resource availability works. There is a huge difference between my situation of one person versus having the luxury of a test team with automated testing.

Thanks in advance,
Eric Kanazawa
Manager, Quality Engineering