Looking for Cross Functional Matrix of Medical Device Regulations around the World

Q

QAengineer13

Quite Involved in Discussions
#1
#1
I'm in search for a cross functional matrix of regulations around the world, any help in this matter will be much appreciated! I have the mapping of 21 CFR and JPAL ....in search for the the rest of the countries
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Ajit Basrur

Ajit Basrur

Staff member
Admin
#2
#2
Re: Looking for Cross Functional Matrix of Medical Device Regulations around the Worl

QAengineer13 said:
I'm in search for a cross functional matrix of regulations around the world, any help in this matter will be much appreciated! I have the mapping of 21 CFR and JPAL ....in search for the the rest of the countries
Click to expand...
What is the purpose of this matrix - are you building the QMS of "around the world" in your existing QMS ?

Marcelo has a valuable post - Guidance for Medical Device Registration in Med Dev Regulations World-Wide in which he has listed all the regulations of different countries. Hope that helps.
 
Q

QAengineer13

Quite Involved in Discussions
#3
#3
Re: Looking for Cross Functional Matrix of Medical Device Regulations around the Worl

Ajit Basrur said:
What is the purpose of this matrix - are you building the QMS of "around the world" in your existing QMS ?

Marcelo has a valuable post - Guidance for Medical Device Registration in Med Dev Regulations World-Wide in which he has listed all the regulations of different countries. Hope that helps.
Click to expand...
Hi Ajit,

Yes, you are correct, that's the idea and thank you to the link for global medical device registration.
 
M

Marcelo

Inactive Registered Visitor
#5
#5
Re: Looking for Cross Functional Matrix of Medical Device Regulations around the Worl

shimonv said:
I'm adding a nice comparison chart of QSR, CMDR, MDD, JAPL, and ANVISA.

Cheers,
Shimon
Click to expand...
I think it's important to mention that, although really nice, the ISO, JPAL and ANVISA requirements are old requirements, not current ones.
 
shimonv

shimonv

Trusted Information Resource
#6
#6
Re: Looking for Cross Functional Matrix of Medical Device Regulations around the Worl

Marcelo,
The reason I uploaded the table was to show the similarity between the major markets when it comes to quality system.
I should have stated that in my previous post. Thanks for your comment.

If someone wants to update the table - please do!

Shimon
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Looking for Cross reference of AS9100:2016 to ISO13485 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
P Looking to outsource Internal Audit - MDSAP competent auditor needed Other Medical Device Regulations World-Wide 9
Q Measurement Equipment Revocation - Looking for a Disposal Form with Risk Assessment IATF 16949 - Automotive Quality Systems Standard 10
B Looking for SSCP file of IVD devices EU Medical Device Regulations 7
M Looking for a copy of ISO 10651 Hospitals, Clinics & other Health Care Providers 6
Azaarus Looking for important points regarding First Piece Inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
L Looking for Control Plan and FMEA Stamping process FMEA and Control Plans 2
Q Looking for a 5S tracking database Problem Solving, Root Cause Fault and Failure Analysis 4
N Looking for a recommendation for an EU MDR Importer EU Medical Device Regulations 1
K Technical file for MHRA - looking for assistance with self declaration Class I device CE Marking (Conformité Européene) / CB Scheme 8
J Looking for partners Paid Consulting, Training and Services 2
bryan willemot Looking for an Approved vendors list template Document Control Systems, Procedures, Forms and Templates 11
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
M Data Protection and Privacy Policy - looking for a template/example EU Medical Device Regulations 1
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
blackholequasar Looking into Nadcap for the first time AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
S We are looking for EU authorised Representative for both Class I and Class IIb devices EU Medical Device Regulations 7
K Looking for a job as Quality Engineer Career and Occupation Discussions 3
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
mihzago Looking for an Australian/ NZ Sponsor Other Medical Device Regulations World-Wide 4
S New Foreign Exporter Looking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
N Looking to Impress - New Job - Advice, Thoughts, Comments Welcome Career and Occupation Discussions 23
J Looking for a training organization that can provide in house DFMEA training FMEA and Control Plans 4
A Looking for a third party to calibrate our measure equipment - South Carolina General Measurement Device and Calibration Topics 6
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
N Looking for Gamma sterilization facility in China ISO 13485:2016 - Medical Device Quality Management Systems 4
A 5 x 5 Risk Matrix - Looking for a good example Manufacturing and Related Processes 2
M Looking for a Presentation on Design for Excellence (DfX) Manufacturing and Related Processes 2
J Looking for a EU MDR Gap Analysis template EU Medical Device Regulations 6
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 1
A New to QC, looking for resources Problem Solving, Root Cause Fault and Failure Analysis 3
bryan willemot Looking for a certified test report for aerospace parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
K I’m looking for a square probe for my linear height gauge Manufacturing and Related Processes 1
C Looking for China Good manufacturing practice China Medical Device Regulations 1
M Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At? EU Medical Device Regulations 7
DuncanGibbons Looking for example aerospace part CAD files to be used for a case study Career and Occupation Discussions 2
A We're currently looking for any studies performed on various PPE materials Qualification and Validation (including 21 CFR Part 11) 1
C Looking for APQP Training recommendations preferably in the aerospace industry APQP and PPAP 2
M Looking for third party reviewers for FDA submissions US Food and Drug Administration (FDA) 2
C Looking for simple Software Validation IQ templates. Qualification and Validation (including 21 CFR Part 11) 4
H Looking for Tips on finding an IATF consultant Consultants and Consulting 6
W My company is looking to start a materials testing lab that conforms to ISO17025:2017 ISO 17025 related Discussions 3
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
bryan willemot Looking for a good CoC to put with my certification sheets when we send parts Document Control Systems, Procedures, Forms and Templates 1
L I'm looking for Translation Procedure Guide MEDDEV 2.5/5 Rev.2 (NOT Rev.3) CE Marking (Conformité Européene) / CB Scheme 0
K Looking for a good Six Sigma book Six Sigma 7

Similar threads

Top Bottom