M
mr.mike
Well Met Everyone!
I was just going through the thread on registrar recommendations, but I'm unsure if I (my company) can relate or not.
The fact is, we are a VERY small (5 people) medical device company, developing only low-to-medium (Class I & II) devices.
As such, I think our criteria may be slightly different from many of you big-players, and I was hoping we could narrow the recommendations based on the above.
Basically, here's what we would be looking for (pretty much in order of priority):
1) Approved by Health Canada (we are from Canada). Their list, however, includes the usual big names: BSI, SGS, QMI, TUV America, TUV Rheinland, Intertek, KEMA, Loyd's, NSAI...
2) 13485, IEC 60601-1 (CB test-report), notified body services
3) Reasonably priced (...did I mention we are a tiny company )
4) Based in North America (not critical, just for logistics)
So, if anyone has any recommendations based on these criteria, it would be greatly appreciated.
Thanks in advance,
MM.
I was just going through the thread on registrar recommendations, but I'm unsure if I (my company) can relate or not.
The fact is, we are a VERY small (5 people) medical device company, developing only low-to-medium (Class I & II) devices.
As such, I think our criteria may be slightly different from many of you big-players, and I was hoping we could narrow the recommendations based on the above.
Basically, here's what we would be looking for (pretty much in order of priority):
1) Approved by Health Canada (we are from Canada). Their list, however, includes the usual big names: BSI, SGS, QMI, TUV America, TUV Rheinland, Intertek, KEMA, Loyd's, NSAI...
2) 13485, IEC 60601-1 (CB test-report), notified body services
3) Reasonably priced (...did I mention we are a tiny company )
4) Based in North America (not critical, just for logistics)
So, if anyone has any recommendations based on these criteria, it would be greatly appreciated.
Thanks in advance,
MM.