ISO 13485 Auditor recommended a monthly MDR Search

5

5106north

#1
This is my first posting. I did a search and couldn't find this question already, and I hope I have put it in the correct forum.

During the ISO audit (9001 and 13485) our auditor recommended checking the FDA site on a monthly basis to see if our device had any MDRs. He said that we could print a copy of the search each month and put in a file folder so that if future auditors requested if we had any MDRs we could prove that we did not.

I've not been able to find anything on the FDA site or within the ISO standards that make this a requirement. We didn't get any nonconformance for it but it still is an open question for me as to why he would have recommended something that seems like "busy work".

Our device is Class II 510k cleared. Has anyone ever encountered this recommendation before or was this auditor off base. Please note that I am pretty new to the medical device industry and this was my first ISO audit.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Welcome to the Cove, 5106north.

I've encountered the same thing - it's a vigilance concern and is scattered throughout the standard. An adverse event could be reported to the FDA, I suppose, without you getting notified.

We had one client who contracted with one of the major 'quality services' shops to develop his QMS. They did a whole SOP on post-market surveillance. In there, they required the client to review specific trade journals (and log on a form that they did it) to identify any feedback / trends on even similar products. Personally, I thought that was over the top (and as it turned out, the client ended up NOT documenting those reviews and would have eventually been written up).

I think the suggestion has merit. What are you / can you do for post-market vigilance? Hopefully some other Covers can share what do for post-market vigilance.
 

somashekar

Staff member
Super Moderator
#3
This is my first posting. I did a search and couldn't find this question already, and I hope I have put it in the correct forum.

During the ISO audit (9001 and 13485) our auditor recommended checking the FDA site on a monthly basis to see if our device had any MDRs. He said that we could print a copy of the search each month and put in a file folder so that if future auditors requested if we had any MDRs we could prove that we did not.

I've not been able to find anything on the FDA site or within the ISO standards that make this a requirement. We didn't get any nonconformance for it but it still is an open question for me as to why he would have recommended something that seems like "busy work".

Our device is Class II 510k cleared. Has anyone ever encountered this recommendation before or was this auditor off base. Please note that I am pretty new to the medical device industry and this was my first ISO audit.
Welcome to the Cove 5106north ...
The recommendation has merit. yoden said you well about it.
PMS wants you to keep your info channels open about your products, similar products, new technologies, new risks so as to bring the state of the art into your system.
What all can you do to make your device more effective and more safe ?
As a system you are required to make these channels always operative, and you decide how you will do this.
 
Thread starter Similar threads Forum Replies Date
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 17
D Impartiality of Internal Auditor ISO 9001/13485 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
C Recommendations for UK-based ISO 13485 internal auditor training ISO 13485:2016 - Medical Device Quality Management Systems 1
J Training documentation - ISO 13485 audit and the auditor had questions General Auditing Discussions 7
J Online ISO 13485 Auditor Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
A ISO 13485 - Internal Auditor Independence and Process Owners ISO 13485:2016 - Medical Device Quality Management Systems 3
GoSpeedRacer Pre-Work and Study for ISO 13485:2016 Lead Auditor Class ISO 13485:2016 - Medical Device Quality Management Systems 1
C ISO 13485:2016 - Internal Auditor Training vs. Lead Auditor Training Training - Internal, External, Online and Distance Learning 4
S Where can I take ISO 13485 lead auditor training? Training - Internal, External, Online and Distance Learning 13
M ISO 13485 Audit Questions - Internal Auditor Training and other Requirements ISO 13485:2016 - Medical Device Quality Management Systems 10
S Can I accomplish ISO 13485 Lead Auditor Training online? Training - Internal, External, Online and Distance Learning 6
Q Need Outsourced ISO 13485/FDA Internal Auditor for a Medical Device Company Internal Auditing 3
B Is the ISO 13485 auditor being too picky concerning CMDCAS? ISO 13485:2016 - Medical Device Quality Management Systems 5
L ISO 13485 Lead Auditor Re-Training Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
E How to become a Certified ISO 13485 Auditor ISO 13485:2016 - Medical Device Quality Management Systems 22
D I will be an ISO 13485 Auditor soon - Your suggestions are appreciated ISO 13485:2016 - Medical Device Quality Management Systems 16
J What do you need to become an ISO 13485 Auditor Career and Occupation Discussions 9
P Can I perform an ISO 13485 audit? I'm a registered RABQSA QMS and AS9100 Auditor ISO 13485:2016 - Medical Device Quality Management Systems 3
J Auditor training - Is there a big difference between auditing ISO 13485 & ISO 9001? ISO 13485:2016 - Medical Device Quality Management Systems 8
A ISO 13485 Clause 8.2.2 - Internal auditor from within the company to be audited Internal Auditing 2
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 5
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom