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:
 
Elsmar Forum Sponsor

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

Problem Solver
Staff member
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

Problem Solver
Staff member
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;)
 
Thread starter Similar threads Forum Replies Date
A Gage R&R With Proportions - Advisable Approach or Not? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
M Is it acceptable or advisable to have a "Quality Systems Glossary"? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
K Advisable Period of Records to be Checked in Conducting an Audit Food Safety - ISO 22000, HACCP (21 CFR 120) 2
M Supplier Survey - Cover letter advisable? Supplier Quality Assurance and other Supplier Issues 10
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
R Exporting to Canada and MDSAP Canada Medical Device Regulations 7
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
M MDSAP and 13485:2016 gap analysis Quality Management System (QMS) Manuals 1
O MDSAP Reduction in Scope Other Medical Device Related Standards 0
M MDR Impact on MDSAP Countries Other Medical Device Regulations World-Wide 16
Watchcat What's up with MDSAP lately? Medical Device and FDA Regulations and Standards News 2
R What happens during a Stage 1 MDSAP audit? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Comparison essential requirements EU compared to those of MDSAP countries Other Medical Device Regulations World-Wide 3
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
J MDSAP Companion and HC requirements Canada Medical Device Regulations 4
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 15
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 5
N MDSAP Participants 2019 - How many companies are participating YTD? ISO 13485:2016 - Medical Device Quality Management Systems 20
B MDSAP 8.2.6 CH6 task 17 ANVISA 16/2013 3.2.1 - Label History in Device history record Other Medical Device Regulations World-Wide 3
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
W Informational MDSAP Substantial change / Change of notice forms Document Control Systems, Procedures, Forms and Templates 2
XRAY_3121 Informational MDSAP Audit Findings - Document change orders Other Medical Device Regulations World-Wide 12
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
B MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device Other Medical Device Related Standards 0
M Medical Device News EU interesting developments – embracing MDSAP and UDI alignment Medical Device and FDA Regulations and Standards News 0
M Medical Device News MDSAP Stakeholder Day – December 5, 2018 presentations Medical Device and FDA Regulations and Standards News 0
Ajit Basrur MDSAP Presentations - Dec 5, 2018 - Stakeholders Other Medical Device Regulations World-Wide 0
JoshuaFroud FDA Form MDSAP AU F0029.1.004 - Help with Completion US Food and Drug Administration (FDA) 0
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
Sidney Vianna Interesting Discussion Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate? Canada Medical Device Regulations 0
T MDSAP AO Cost ISO 13485:2016 - Medical Device Quality Management Systems 2
Q MDSAP Regions and how to include in procedures Other Medical Device Related Standards 2
S Initial Importer and ISO 13485 (MDSAP) - Will the US company be included? ISO 13485:2016 - Medical Device Quality Management Systems 1
S MDSAP Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
K MDSAP scope vs ISO 13485 Scope Canada Medical Device Regulations 4
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
M MDSAP Transition - Health Canada Website Notice on Apr 13 2018 Canada Medical Device Regulations 1
D How will the new MDSAP requirements affect the MDEL? Canada Medical Device Regulations 1
B Our NB doesn't accept new clients for MDSAP Canada Medical Device Regulations 8
A MDSAP benefit for manufacturer of low-risk devices Canada Medical Device Regulations 3
R Impact of an MDSAP certificate with all countries coverage Other Medical Device Regulations World-Wide 8
A ISO-13485 7.1 - Preparing for our MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
M What is a reasonable MDSAP cost? ISO 13485:2016 - Medical Device Quality Management Systems 9
Edward Reesor Canadian News article on impact of MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 10
C Substantial Change in MDSAP Audit Other Medical Device Regulations World-Wide 1
S How can we demonstrate to MDSAP auditors that we have the requisite training ISO 13485:2016 - Medical Device Quality Management Systems 9
T MDSAP readiness - Selling clinical product IVDs into Canada Canada Medical Device Regulations 7
F MDSAP vs "Full" FDA Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Question about Australia - TGA and MDSAP - Technical file ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom