When you began your medical device company, you had an idea – and maybe a prototype, funding, and some customer interest.

At what point did you start implementing a quality system? It’s required to generate the product documentation for regulatory approvals. And implementing one is a big task for a small company with limited resources.

How did you develop a quality system from scratch? If you implemented your quality system over time, what processes did you tackle first?

I’m asking on behalf of group member Maren Nelson, a seasoned quality / engineering / program director now consultant, who can’t find a suitably affordable off-the-shelf quality solution for her younger clients.

“I know a company that used to offer one but client customization was too time-consuming,” said Advisory Board member Rob Packard. “That might be another way of saying, ‘It wasn’t making us any money.'”

Are you aware of any off-the-shelf quality solutions that, with minor tweaks, could be adapted for medical device startups?

What features would you want in such a product?

You can reach Maren at http://linkd.in/1i3NEmt

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DISCUSSIONS THIS WEEK

Wow. Medtronic buys Covidien. What are your thoughts?
http://bit.ly/MDT-COV

Benchmarking Quality Policy
http://bit.ly/bnchmarking

What are the top challenges in selling product support services in Asia?
http://bit.ly/svcs-in-Asia

How important is cyber-security in your new product development plans?
http://bit.ly/cybersecurty
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Available for download: 10x presentation “Thinking Globally During Medical Device Development: Accelerating Products to International Markets.”

Full recording and transcript at http://medgroup.biz/intl-development

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http://medgroup.biz/choose-next-years-topics

Should take two minutes. Thanks in advance.

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. If you’re a drive from Seattle, join me Thursday at “Life Science Innovation Northwest” from the Washington Biotechnology and Biomedical Association. 1,000+ guests expected. See http://medgroup.biz/Innovation-Northwest

Rob Packard
510(k), CE Marking & Quality System Consultant
There are 19 procedures required for ISO 13485 and 24 required for 21 CFR 820. Most of these overlap, but ultimately you need about 30 procedures for a new quality system. Instead of trying to do everything at once, I recommend implementation of one procedure at a time. A pace of one per week is usually about right–especially if you include time for training.

The first procedures are typically:
1. Document control
2. Control of Records
3. Purchasing
4. Design Controls