1. We have a full quality system certification, including Design Controls.
2. We had our MDD audit and since we had recently had our 13485 surveillance audit by the same notified body, they basically just looked at the provisions which were specific to MDD, beyond the requirements of 13485, like 14971:2012, European vigilance etc. So that was easy enough and took about a day and a half to audit.
3. I didn't get a quote for Annex VI, but I saw that it still required an on-site audit and I assumed it would take at least a day also, therefore, not a big difference in cost.
I'm also not sure how the weaker Annex would limit us if we don't have Class III devices, but since I was unsure, I tried to take the safer choice.
Thanks,
Christie
Hi,
The good thing is that it's done and you're happy with the results.
For others who come across this thread:
2. 1.5 days is a LONG audit for class IIa with full ISO 13485 certification... Basically, the NB is not supposed to challenge your QMS if you already have it certified to ISO 13485, and was only recently surveyed (but they do sometimes, I know), and there isn't a lot more to it in terms of auditing. I've witnessed 1-day audits for similar class devices (spec developers) that also included a certification audit to 13485 & 9001 at the same time. The auditor simply was effective and efficient and didn't play around (and yes, it was a rather long day). BTW, ISO 14971 is not a MDD requirement more than it is an ISO 13485 one; it's a recommendation in both, and since (I assume) you already complied with it during your ISO 13485 certification, it should have already been covered by the ISO 13485 auditor. Strange...
3. I'm sure there would have been a non-negligible price difference; auditing costs don't end on audit day - there's also some desktop audit prior to that, and sometimes also after. Unless, of course, that NB is there for making a buck (it happens), in which case I wouldn't be surprised if the 1.5 days extent was set upfront, regardless of any specifics. Personally, I would think twice before engaging such a NB, because it would tell me they're either too business-oriented or just inefficient. I'm not sure what's your role in the company, but if I was the CEO I would have definitely asked what's the cost implication of going for the "stronger" annex; not just in the NB bill, but also in the company conduct, longer term, so I could do a benefit per cost analysis. While QA / regulatory professionals normally look for safety / confidence, CEOs normally look for the highest ROI...
I found it intriguing that you mentioned "ISO 14971:2012" (actually it's
EN ISO 14971:2012 in that context) as a MDD requirement. Nothing wrong with mentioning EN ISO 14971 in general; however, the 2012 revision of that standard essentially said the the standard in its current form
doesn't satisfy the MDD requirements...
Cheers,
Ronen.