Is it advisable to do MDSAP and ISO 13485:2016 at the same time?

#1
Hi everyone,

The company I work at is currently ISO 13485:2003 certified. We have not transitioned to ISO 13485:2016 yet. With MDSAP coming up, is it advisable to do MDSAP and ISO 13485:2016 at the same time?

Step 1: Transition to 13485:2016
Step 2: MDSAP audit for 13485:2016

What kind of timeline are we looking at between now and January 2019?

Thanks. :thanx:
 

isolytical

Involved In Discussions
#2
MDSAP applies to the AO, setting auditing requirements for the AO, not to the manufacturer. The manufacturer, if utilizing an MDSAP recognized AO, may contract the AO to perform an MDSAP audit.
 

Jane's

Involved In Discussions
#4
We are in Canada and I would absolutely have done it given a chance, as it saves a ton of money and time. If in Canada, just prepare for ISO 13485:2016 and you should be ready for both HC and FDA components of MDSAP. Most 'novelties' in 2016 standard are FDA QSR requirements like preventing mix-ups (GMP), training effectiveness, Medical Device File i.e. DMR, etc.). Doing the audit first with your internal auditor before meeting the AO will help you nail down any minor wrings.
 
Last edited:

Ronen E

Just a person
Super Moderator
#5
We are in Canada and I would absolutely have done it given a chance, as it saves a ton of money and time.
I agree that for orgs in Canada / selling into Canada doing 13485 & MDSAP together makes sense, because MDSAP will soon be mandatory for them. However, for other orgs adding MDSAP on top of 13485 might actually be more expensive / burdensome than 13485 + other specific domains regulatory audits.

If in Canada, just prepare for ISO 13485:2016 and you should be ready for both HC and FDA components of MDSAP.
I wouldn’t go as far as saying that ISO 13485:2016 compliance covers all FDA requirements, except for in the general sense that ISO 13485 requires compliance with all applicable regulatory requirements (in that general sense preparing for “just” ISO 13485 covers any and all regulatory domains the org distributes in).

Most 'novelties' in 2016 standard are FDA QSR requirements like preventing mix-ups (GMP), training effectiveness, Medical Device File i.e. DMR, etc.).
First, this is a strange statement to me and I would look for confirmation from people who were actually involved in creating the 2016 revision (e.g. Marcelo Antunes).

Specifically, the requirement for a medical device file was already there in the 2003 revision and it indeed resembled the DMR, in a way. The 2016 requirements under medical device file are different from DMR requirements in some clear ways.
 

Jane's

Involved In Discussions
#6
The 2016 requirements under medical device file are different from DMR requirements in some clear ways.
If you don't mind, could you please elaborate in what clear ways are the QSR DMR and MDF as per ISO 13485:2016 different. IIRC, they both require the same: intended use, specifications, manufacturing, labeling, packaging, monitoring, traceability, installation, and/or servicing.
 
Last edited:

Jane's

Involved In Discussions
#8
Thanks for that Ronen. Might be the 3 pm slump, but the differences stated in that discussion were not clear to me. Thanks anyway, appreciate the effort.
 

Ronen E

Just a person
Super Moderator
#9
Thanks for that Ronen. Might be the 3 pm slump, but the differences stated in that discussion were not clear to me. Thanks anyway, appreciate the effort.
In a nutshell, ISO 13485:2016 4.2.3 requires that the medical device file contains evidence for compliance with the requirements of ISO 13485:2016 and with applicable regulatory requirements. Not something that is required to be in a DMR (essentially a recipe for the medical device).
 

Jane's

Involved In Discussions
#10
Thanks for that distinction, Ronen. I will agree to disagree.

The required content of the medical device file is identical to the required content of the DMR and the fact that you have that content demonstrates your conformity to the requirements. From the standard: "one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements."

In addition, all your SOPs (including "procedures for manufacturing, packaging, storage, handling and distribution") should point to the ISO standard and your Quality Manual, and for that reason I see no need for a whole separate file just to be able to call it medical device file.

I'll probably eat a crow if ever confronted with an auditor of your point of view but until then - wooptido;)
 

Top