Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability?

#1
What is the certification procedure for OEM/PLM collaboration in the medical device industry in the US? Who must bear the regulatory responsability?
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Usually the PLM would bear that responsibility, but to make a determination in a specific case access to the actual details is required. Namely, who they are, what each does and what's in the labeling.
 
#3
What are the regulatory responsibilities of an OEM and a Private Label manufacturer within the medical device industry in Canada? Can the PLM refer to the technical file of the OEM? How common is this business model in this country?
 
Last edited:
#4
What are the regulatory responsibilities of an OEM and a Private Label manufacturer within the medical device industry in Japan? Can the PLM refer to the technical file of the OEM? How common is this business model in Japan?
 
Last edited:
#5
What are the regulatory responsibilities of an OEM and a Private Label manufacturer within the medical device industry in China? Can the PLM refer to the technical file of the OEM? How common is this business model in China?
 
Last edited:
#6
What are the regulatory responsibilities of an OEM and a Private Label manufacturer in the US? Can the PLM refer to the technical file of the OEM?
 
#7
What are the regulatory responsibilities of an OEM and a Private label manufacturer within the medical device industry in Australia? Can the PLM refer to the technical file of the OEM? How common is this business model in Australia?
 
Last edited:
#8
What are the regulatory responsibilities of an OEM and a Private label manufacturer within the medical device industry in South Africa? Can the PLM refer to the technical file of the OEM? How common is this business model in the aforementioned country?
 
#9
What are the regulatory responsibilities of an OEM and a Private Label manufacturer withing the medical device industry in the US? Can the PLM refer to the technical file of the OEM? How common is this business practice in this country?
 
Thread starter Similar threads Forum Replies Date
DuncanGibbons Additive Manufacturing/3D printing for aerospace (certification procedure) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
K Halal Certification Procedure and Requirements help and examples wanted Food Safety - ISO 22000, HACCP (21 CFR 120) 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
K USB VID/PID certification Various Other Specifications, Standards, and related Requirements 2
L IATF 16949 certification costs IATF 16949 - Automotive Quality Systems Standard 3
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
R China Quality Certification Various Other Specifications, Standards, and related Requirements 1
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
N Any experience with Registrars that deny Certification to a Registrant? Registrars and Notified Bodies 4
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
J Hitrust Certification (HIPPA etc.) Other Medical Device Regulations World-Wide 0
T Letter to file for Product Certification CE Marking (Conformité Européene) / CB Scheme 0
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
M What happens to certifications if the issuing certification body loses accreditation? Supplier Quality Assurance and other Supplier Issues 2
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 0
K Regulatory Affairs Certification (RAC) Exam - November 2020 preparation Professional Certifications and Degrees 0
B Advantages of a corporate certification scheme IATF 16949 - Automotive Quality Systems Standard 8
N Harmonized Standards for MDR Certification EU Medical Device Regulations 7
M Quality management certification required by Health Canada Canada Medical Device Regulations 3
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
M OEM asking for NC report after certification audit. IATF 16949 - Automotive Quality Systems Standard 3
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
T AMS2570E certification equipment questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S RA (Regulatory Affairs) certification & Online Internship Professional Certifications and Degrees 11
B Directory of Largest Global Certification Bodies (Accredited) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 3
M CE self-certification for Class I device (face mask) EU Medical Device Regulations 9
D API 6A Certification Question Oil and Gas Industry Standards and Regulations 4
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
michellemmm What is the Cost of six sigma certification? Six Sigma 5
L "IATF-Compliant" IATF 16949:2016 certification? What does this mean? IATF 16949 - Automotive Quality Systems Standard 13
V Iso13485 certification vs CE technical audit ISO 13485:2016 - Medical Device Quality Management Systems 3
Watchcat Duration of MDD Certification EU Medical Device Regulations 4
DuncanGibbons FAA's Building Block approach to certification Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
J Product Service after CE Certification expiration CE Marking (Conformité Européene) / CB Scheme 1
G USAS ISO 9001 Certification, online is it worth it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
W Certification for IATF Lead Auditor will expire in 2020 IATF 16949 - Automotive Quality Systems Standard 2
M Using your Manufacturer's ISO certification ISO 13485:2016 - Medical Device Quality Management Systems 5
M Define voltage and frequency to perform tests 61010-1 and 61326-1 for CE certification CE Marking (Conformité Européene) / CB Scheme 4
Nicole Desouza ISO / AS Certification - Small business with less than 100 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna IATF 16949 News Presentations from the latest IATF Stakeholder Event - Expectation that IATF 16949 certification should equate with product quality. Misguided? IATF 16949 - Automotive Quality Systems Standard 7
O ISO 9001 new certification advice request - Develop a QMS from scratch ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14

Similar threads

Top Bottom