Medical device file Vs Role undertaken by the organization

somashekar

somashekar

Leader
Admin
#1
#1
When the role undetaken by the organization A is that of distribution, installation and servicing of the Medical device, and that medical devcie is designed and manufactured by the organization parent company B, which is not covered under the scope of organization A certification., How should the organization A address the requirement a) under the clause 4.2.3 of ISO 13485:2016... (Medical device file) Please share your views
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
D

DannyK

Trusted Information Resource
#2
#2
This is what I would write in 4.2.3.
As an organization providing distribution, installation and servicing, the medical device file only includes activities related to these activities for the medical device. The legal manufacturer of the devices is responsible for maintaining the medical device files as per the requirements of ISO 13485:2016 clause 4.2.3.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 3
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
Sam Lazzara Medical Device File (MDF per 13485:2016 4.2.3) versus FDA Device Master Record (DMR) ISO 13485:2016 - Medical Device Quality Management Systems 3
O Medical Device Technical File Confidentiality - On site reviews EU Medical Device Regulations 14
M Medical Device Master File - We are a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 10
S Medical Device Cybersecurity Risk Management File ISO 14971 - Medical Device Risk Management 2
J One Medical Device, two indications, two classes, one technical file? EU Medical Device Regulations 4
C Medical device file for components such as adhesives, gaskets, films, etc. ISO 13485:2016 - Medical Device Quality Management Systems 13
TheMightyWife Virtual Manufacturer v Medical Device File (NB audit) EU Medical Device Regulations 12
A Technical file requirement for Class IIb medical device CE Marking (Conformité Européene) / CB Scheme 3
Q Is a DHR enough to fulfill 13485:2016's Medical Device File requirement? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Looking for an example of a medical device file ISO 13485:2016 - Medical Device Quality Management Systems 1
Sam Lazzara Medical Device File Requirements (ISO 13485 Cl. 4.2.3) ISO 13485:2016 - Medical Device Quality Management Systems 11
C ISO 13485 Medical Device File requirements for IVD ISO 13485:2016 - Medical Device Quality Management Systems 1
U Medical Device File For Repair and Resale ISO 13485:2016 - Medical Device Quality Management Systems 2
J How to document Corrections made to a Medical Device History File ISO 13485:2016 - Medical Device Quality Management Systems 1
J 510k file requirements for non-sterile medical device accessories 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A DHF (Design History File) for a Legacy Product (Class iii Medical Device) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
E When to submit a Technical File for a Class IIb Medical Device EU Medical Device Regulations 3
Q Technical File for Medical Device Accessories CE Marking (Conformité Européene) / CB Scheme 4
L Labeling Requirements in Part A Class IIb Medical Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
I Foreign Medical Device Manufacturer Complaint File Establishment US Food and Drug Administration (FDA) 2
T Class IIa Medical Device Technical File - Annexes EU Medical Device Regulations 6
O Medical Device Registration in EU - Which Ministry to submit Technical File? EU Medical Device Regulations 9
M Medical Device Technical File SOP example available? EU Medical Device Regulations 14
S What constitutes a Medical Device Technical File "Family?" EU Medical Device Regulations 6
A Medical Device DHF (Design History File) - One per Design Change? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
L Creating DHF (Design History File) for Medical Device Systems Design and Development of Products and Processes 8
rob73 Transfer of Technical File, CE Mark etc., for an OEM Medical Device EU Medical Device Regulations 3
M Example of a Risk Assessement File for Medical Device Other ISO and International Standards and European Regulations 5
U What is a Medical Device "Master Item File"? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L Class 1 Medical Device Contract Manufacturer Technical File Requirements Design and Development of Products and Processes 3
S How big is your Medical Device Technical File? CE Marking (Conformité Européene) / CB Scheme 3
S Medical Device Technical File/Dossier (CE Mark) review - How many ?experts? available CE Marking (Conformité Européene) / CB Scheme 3
C Class II Medical Device Technical File Checklist CE Marking (Conformité Européene) / CB Scheme 20
N Control of Medical Device DHF (Device History File) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
rob73 Technical File Information on Moulded Parts of a Medical Device EU Medical Device Regulations 5
M Medical Device Testing Based in Manchester? Consultant to open Technical File EU Medical Device Regulations 4
S How do I create a Technical File for a Class IIa Medical Device EU Medical Device Regulations 5
M Documentation of OEM Device - Technical File for a Class IIa Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 4
Q When to File an MDR (Medical Device Reporting) For Incidents in Foreign Countries 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Is Site Master File necessary for a European Medical Device Manufacturer (class III)? ISO 13485:2016 - Medical Device Quality Management Systems 5
S Requirements for Updating a Medical Device Technical File EU Medical Device Regulations 13
Q DHF (Design History File) on New Medical Device Product ISO 13485:2016 - Medical Device Quality Management Systems 9
M Design History File - Medical Device Quality Systems Manual Section 3, Design Control Design and Development of Products and Processes 1
B Telemedicine as a Medical Device EU Medical Device Regulations 4
S Definition of disease as per medical device defintion EU Medical Device Regulations 14
Q Class I Medical Device with measuring function (UK MDR 2002 / MDD) UK Medical Device Regulations 3
G No new regulations in Austria medical device register after 26th Mai, 2022 EU Medical Device Regulations 0
A What activities are included in the action of marketing you medical device in U.S.? Medical Device and FDA Regulations and Standards News 1

Similar threads

Top Bottom