🔥 Find me at MedicalDevicesGroup.net 🔥
2 min reading time
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
DISCUSSIONS THIS WEEK
Wow. Medtronic buys Covidien. What are your thoughts?
Benchmarking Quality Policy
What are the top challenges in selling product support services in Asia?
How important is cyber-security in your new product development plans?
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
If you appreciate these Medical Devices Group updates, please take this quick survey:
Should take two minutes. Thanks in advance.
Make it a great week.
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
The first procedures are typically:
Marked as spam