Can a Consultant be the main contact for a Medical Device Company?

[MiaQMS]

Can I ask a generic question here regarding the use of consultants...sorry in advance if this has already been addressed.

Can a Consultant, specifically those who help out Medical Device Companies, be the main contact for a the certification body, or does there need to be a Quality representative based in the company too? I ask, because my company wants to employ a consultant rather than an onsite Quality/RA Manager and I wanted to know if this was ok to do so.

Background information: The company is based in the UK, currently hold ISO13485 and MDD certification for Class IIa and IIb devices on the market. TIA

 

[fialor]

MiaQMS, It is possible to do but not ideal.
The requirement is to be able to demonstrate that there sufficient resources to support the implementation and effective management of the QMS. If the consultant can do this then it is ok.
The best approach I think would be to speak with your NB as they can be advise. Though in my experience unless your business is extremely small, NBs prefer that the contact with them is an effective employee.

 

[robertjbeck]

As a consultant, I have done this for several of my client companies. I find that NB's appreciate professional handling of their inquiries. It can be a problem sometimes if too much responsibility is turned over to a consultant, but in today's business environment this is not unusual.

if the company does have a permanent employee who will responsibly deal with these types of communications and forward them appropriately, then that is better. But it does no good and can cause harm if the employee ignores them because regulatory/quality issues are not in his/her job description or tries to answer questions without having the knowledge to do so.

 

[MiaQMS]

Thank you FIALOR and ROBERTJBECk for your responses. These have been really useful, I wondered was there something in the Directive or standard that didn't allow this but it makes more sense now and I'm glad to hear that it is 'allowed' per se.

 

[Julie O]

As a regulatory consultant, I wouldn't recommend it. I would also say that it's not a good sign if the company has no permanent employee responsible for their QMS that can handle the NB's inquiries professionally. Regardless, I would not use the same contact for ISO 13485, which is a quality standard, and MDD certification, which is a regulatory requirement. Quality and regulatory are two separate areas of expertise.

 

[robertjbeck]

theoretically your answer is correct. in the real world, with small to mid-size companies, management may not be aware of such subtle distinctions between regulatory and quality standards. there is often a lack of understand about which standards apply. as for quality and regulatory being two separate areas of expertise, yes that's correct especially when applied to software but it's also irrelevant. these two areas are tightly linked, for instance in Canada, the Canadian Medical Device Regulations are very applicable to ISO 13485 audits. Try getting through a medical device quality systems audit ignoring those regulations ...

 

[Julie O]

Companies that do not market medical devices in Canada get through ISO 13485 audits all the time without anyone in the company knowing a thing about the Canadian regulations. Similarly, companies that are not legal manufacturers of CE Marked medical devices get through ISO 13485 audits all the time without knowing a thing about the MDD.

It is also possible to get through an MDD audit without knowing ISO 13485, since an MDD audit is a device-specific audit, not a systems audit, and focuses on conformance to the Essential Requirements, not on quality management.