ISO 13485 certificate needed if I go for MDSAP certification?

Q

QuickSpace

Starting to get Involved
#1
#1
Hi All,

Just curious about this query, Maybe it sounds silly. Just wanted to know if we have to get ISO 13485 certificate if I have MDSAP certification.
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
GStough

GStough

Leader
Super Moderator
#2
#2
That could depend. Do your customers require it? Some customers do require an ISO certificate. Do you sell into countries other than the five that are included in the MDSAP scheme? MDSAP certificates may not hold value in those countries, whereas an ISO 13485 certificate would. Would your company receive any value for obtaining a 13485 certificate?
 
ChrisM

ChrisM

Quite Involved in Discussions
#4
#4
^
What DannyK said, MDSAP "automatically" means ISO13485 and more......

Just to clarify, you don't need to already hold ISO13485 registration, if you go from zero to MDSAP, this includes gaining ISO13485 registration as part of the MDSAP assessment
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B ISO 13485 Certificate Location / Scope ISO 13485:2016 - Medical Device Quality Management Systems 9
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
H Transferring an ISO 13485 certificate to a new CB - Do I have to start from scratch? ISO 13485:2016 - Medical Device Quality Management Systems 2
GStough Informational SN EN ISO 9001:2015 and SN EN ISO 13485:2016 on Same Certificate? Registrars and Notified Bodies 7
T Software Validation Certificate (ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 19
R ISO 13485 Certificate Scope modified by Notified Body EU Medical Device Regulations 9
B Reapplying for ISO 13485 certification after certificate revocation ISO 13485:2016 - Medical Device Quality Management Systems 3
N "Sterile" missing on the CE Certificate - ISO 13485 Certified Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 5
Y Which version of ISO 13485 would be considered for MDSAP certificate? Canada Medical Device Regulations 8
S BSI's ISO 13485 certificate does not mention AC 2009 corrigendum Registrars and Notified Bodies 5
5 Transfer of an ISO 13485 Certificate to another Company ISO 13485:2016 - Medical Device Quality Management Systems 4
D Using a different Notified Body for ISO 13485 Certification & Device Certificate CE Marking (Conformité Européene) / CB Scheme 6
C Validity of a 5 year ISO 13485 Certificate ISO 13485:2016 - Medical Device Quality Management Systems 3
N Scope of ISO 13485 Certificate for Multiple Devices EU Medical Device Regulations 4
N New Certificate for ISO 13485 & CMDCAS has no product listed nor explicit CMDCAS refs ISO 13485:2016 - Medical Device Quality Management Systems 5
C Lapse between ISO 13485 certificate expiring and new audit ISO 13485:2016 - Medical Device Quality Management Systems 9
K ISO 13485 Registration Certificate Life-Time (Validity Period) ISO 13485:2016 - Medical Device Quality Management Systems 21
Q ISO 13485 Certification - Single ISO certificate for two different business entities? ISO 13485:2016 - Medical Device Quality Management Systems 4
B Reference to EN550 or ISO11135 - on an ISO 13485 Certificate ISO 13485:2016 - Medical Device Quality Management Systems 2
LostLouie DHF linked to ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 4
M ISO 13485 Supplier Question ISO 13485:2016 - Medical Device Quality Management Systems 13
M ISO 13485:2016 Identification & Traceability ISO 13485:2016 - Medical Device Quality Management Systems 4
K Clause 7.5.2 of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J ISO 13485 and new warehousing ISO 13485:2016 - Medical Device Quality Management Systems 2
A Applying for ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 8
Ed Panek Auditor Feedback ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 12
S ISO 13485 certification training Training - Internal, External, Online and Distance Learning 1
Ed Panek ISO 13485 Reporting Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 13485 Qualification of R&D Equipment Qualification and Validation (including 21 CFR Part 11) 1
J Recognised/reputable courses for ISO 13485 Section 7.3 (Design & Development)? ISO 13485:2016 - Medical Device Quality Management Systems 1
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 11
P Registrar Cancelled ISO 13485 Auditors multiple times? Registrars and Notified Bodies 1
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 4
FuzzyD ISO 13485:2016 Customer Assessment OFI ISO 13485:2016 - Medical Device Quality Management Systems 2
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 7
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
ISO-tired ISO 13485: file structure overview ISO 13485:2016 - Medical Device Quality Management Systems 11
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
S ISO 13485 signing of Procedures etc. ISO 13485:2016 - Medical Device Quality Management Systems 10
N ISO 13485 Scope Reduction Other ISO and International Standards and European Regulations 2
M Can veterinary implants be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 23
D Audit Report details when ISO 13485:2016 and cGMP 21 CFR 820 are applicable ISO 13485:2016 - Medical Device Quality Management Systems 6
R Looking for ISO 13485 Internal Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 8
FuzzyD ISO 13485 change in process ISO 13485:2016 - Medical Device Quality Management Systems 3
R Interesting Discussion Chapter 7.5 of ISO 13485 for manufacturers of mobile medical applications ISO 13485:2016 - Medical Device Quality Management Systems 4
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Subcontractors Providing Services Under MDD or MDR need ISO 13485 from EU Notified Body? CE Marking (Conformité Européene) / CB Scheme 8

Similar threads

Top Bottom