Iso13485 certification vs CE technical audit

#1
We work on a class 1m device, We have implemented iso13485.

We would like to know Is it mandatory to get our system certified as a proof for demonstrating conformity or wait for the entire product lifecycle to be completed and go for design dossier file audit along with iso13485 ? Will we be audited again as a part of CE technical audit for which we have to spare the same cost again ?

Which would be a better strategy and what will be the implications ?
 
Elsmar Forum Sponsor
#2
Dear vishnums,

please clarify the question:
Is the quality management system (QMS) only implemented or is it already certified?
Where do you want to register the class 1m device?
What do you mean with "wait for the enitre product lifecycle to be completed"?

Kind regards
thinqbetter
 
#3
Is the quality management system (QMS) only implemented or is it already certified?
QMS is only implemented but not certified.
Where do you want to register the class 1m device?
In Europe
What do you mean with "wait for the enitre product lifecycle to be completed"?
We are in the process of completing our production process validation and do a pilot production.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
We work on a class 1m device, We have implemented iso13485.

We would like to know Is it mandatory to get our system certified as a proof for demonstrating conformity or wait for the entire product lifecycle to be completed and go for design dossier file audit along with iso13485 ? Will we be audited again as a part of CE technical audit for which we have to spare the same cost again ?

Which would be a better strategy and what will be the implications ?
Is the quality management system (QMS) only implemented or is it already certified?
QMS is only implemented but not certified.
Where do you want to register the class 1m device?
In Europe
What do you mean with "wait for the enitre product lifecycle to be completed"?
We are in the process of completing our production process validation and do a pilot production.
Hi,

If you work at a (relatively) new company or on a new class 1m device which you'd like to introduce in Europe, you might be in trouble until at least the end of 2020. You'll need a Notified Body (NB) intervention and currently it seems that they're all overbooked (and overwhelmed) and not taking on new customers / projects.

Once you manage to engage with a NB they'll need to audit you on-site, addressing the measurement aspects (only) of your device. In that regard they will also audit your QMS - ISO 13485 certification is NOT mandatory for EU certification, but it's the most straightforward path for proving QMS complaince with the EU MDR, and NB's preferred path. So theoretically no, it's not mandatory, but practically pretty much...

For ISO 13485 certification you don't have to have "the whole product lifecycle completed" - you will be audited on having all the required QMS infrastructure in place (even parts you're not using yet - assuming they're going to become relevant in, say, the 12 months following certification), and on the implementation of the parts that are already set in motion. However, for getting your device EC certified by the NB (probably what you refer to as "CE technical audit" or "design dossier file audit"), its design and manufacturing setup must be complete to an extent. I would say you'd need to complete design validation and design transfer, and be already running commercial pilot production, at least. In the EU, you can't get certified for a "theoretical" device (like clearing a 510k in the USA regardless of production).

When you're ready (and a NB is available) you can have a single audit that covers the QMS and the device (the technical file) - again, for a class 1m device only the measurement function aspects will be audited; other than that it's a class 1 device and your compliance is self-certified for all OTHER aspects.

Cost-wise it's obviously better to do everything in one go (unless you're active in other markets as well where some value can be gained from a stand-alone ISO 13485 certification, while you're waiting for a NB to become available).

Good luck (you will need it),
Ronen.
 
Last edited:
Thread starter Similar threads Forum Replies Date
C Is there a strong market out there for ISO13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 11
S CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Audits ISO 13485:2016 - Medical Device Quality Management Systems 7
J ISO13485 Certification Scope - Registering a Subset of our Products ISO 13485:2016 - Medical Device Quality Management Systems 9
M ISO13485:2003 - Certification Bodies are accredited by UKAS ISO 13485:2016 - Medical Device Quality Management Systems 10
A Is it mandatory to obtain ISO13485 certificate prior to CE marking? EU Medical Device Regulations 8
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
A Document "Correspondence IATF 16949 vs ISO13485" available? IATF 16949 - Automotive Quality Systems Standard 0
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 8
N Can a (class I) medical device be manufactured in a GMP certified site with no ISO13485? EU Medical Device Regulations 18
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO13485:2016 7.5.6 Process Validation Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 1
D Customer Audit Finding ISO13485:2016 7.6 ISO 13485:2016 - Medical Device Quality Management Systems 7
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
R How to improve a Validation program and procedures to FDA (21 CFR part 820) & ISO13485 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S PPT for ISO13485:2016 Employee Training (Request) ISO 13485:2016 - Medical Device Quality Management Systems 0
qualityegghead ISO13485:2016 4.2.4 Control Of Documents - Lifetime of the Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
S Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness ISO 13485:2016 - Medical Device Quality Management Systems 13
C ISO13485 exclusions for design and automation company ISO 13485:2016 - Medical Device Quality Management Systems 2
R ISO13485/ISO9001 Convenient Document Management System Document Control Systems, Procedures, Forms and Templates 3
S ISO13485 2016 - What the upshot is of failing to upgrade on a medical diagnostic device ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO9001 & ISO13485 QMS for 2 types of products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M ISO13485 Documentation packs (manual, procedures, forms etc) ISO 13485:2016 - Medical Device Quality Management Systems 3
H ISO13485:2016 Measurement System - Methods General Measurement Device and Calibration Topics 4
C ISO13485/9001 clause 6.3 (Infrastructure) ISO 13485:2016 - Medical Device Quality Management Systems 3
G ISO13485:2016 Cl. 7.5.1 - Production and Service Provision - Medical Device Repairs ISO 13485:2016 - Medical Device Quality Management Systems 3
M Looking for Cross reference of AS9100:2016 to ISO13485 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M ISO13485:2016 - Exemption vs. Not Applicable ISO 13485:2016 - Medical Device Quality Management Systems 16
K Implementing ISO13485:2016 in the Middle of a New Device Project ISO 13485:2016 - Medical Device Quality Management Systems 1
T ISO13485:2016 Clause 6.3 - Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO13485:2016 Clause 4.2.3 - Changes in Technical File Requirements ISO 13485:2016 - Medical Device Quality Management Systems 18
T ISO13485 cert expired - Product still CE Marked CE Marking (Conformité Européene) / CB Scheme 1
V Revised ISO std vs ISO13485:2003 - Help Please!!! ISO 13485:2016 - Medical Device Quality Management Systems 4
B Must a Design Outsourcing Company have ISO13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
L ISO13485 past practice labeling vs customer requirement Other ISO and International Standards and European Regulations 2
quality1 Multiple Quality Standards - AS9100 and ISO13485/9001 Cross Reference Matrix Quality Manager and Management Related Issues 3
C ISO13485 Incoming Receiving Parts Verification ISO 13485:2016 - Medical Device Quality Management Systems 13
Q ISO13485 Section 7.5.1.1 and 7.5.2.1 for a Distributor ISO 13485:2016 - Medical Device Quality Management Systems 2
W Setting up from scratch - Looking for help (ISO9001 / ISO13485) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Outsource Production Line need ISO13485 Certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
somashekar Clause 7.5.5. as in the text and in the Annex B (ISO13485:2003) ISO 13485:2016 - Medical Device Quality Management Systems 1
U Do we have to have foreign legal documents? (ISO13485 4.2.3 document control) ISO 13485:2016 - Medical Device Quality Management Systems 3
0 Medical Device Distribution Centre and Implementing ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
C Writing a Sterilization Procedure when the Process is Subcontracted - ISO13485 Quality Management System (QMS) Manuals 1
J ISO13485 Clause exclusions for a Medical Software Company ISO 13485:2016 - Medical Device Quality Management Systems 9
P How to streamline different documents in a multi plant ISO13485 QMS ISO 13485:2016 - Medical Device Quality Management Systems 8
D FDA Guidance on Interim Use of ISO13485 for Medical Device Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
S Implementing ISO13485 in a new startup company - Neurological devices ISO 13485:2016 - Medical Device Quality Management Systems 12
E Career Plan - ISO13485 Lead Auditor Course/IRCA certified ISO9001 Lead Auditor Course Professional Certifications and Degrees 4
S Scope of ISO13485 and the term 'Related Services' ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom