Medical Device - Technical Documentation structure

#1
Hi everyone,

I am currently developping regulatory affairs strategy in my company for manufacturing of medical devices.
As an important part of this strategy, there is the Technical Dossier structure.
We are exploring different alternatives and one of these is the IMDRF/RPS WG/N9(Edition 3) FINAL:2019 - Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVDMAToC)

Does anybody have experience with this TD structure? How is it considered by notified bodies for ISO13485 and CE (MDR) certification?

Thanks,
SImon
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 4
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 3
O Medical Device Technical File Confidentiality - On site reviews EU Medical Device Regulations 14
J One Medical Device, two indications, two classes, one technical file? EU Medical Device Regulations 4
A Technical file requirement for Class IIb medical device CE Marking (Conformité Européene) / CB Scheme 3
S Medical Device Registration & Technical Format/Template - European Union CE Marking (Conformité Européene) / CB Scheme 8
J Software for maintaining of Technical files and medical device documentation(RA need) Medical Information Technology, Medical Software and Health Informatics 2
E When to submit a Technical File for a Class IIb Medical Device EU Medical Device Regulations 3
C Signing of Drawings and Technical Specification in Medical Device EU Medical Device Regulations 5
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
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
rob73 Transfer of Technical File, CE Mark etc., for an OEM Medical Device EU Medical Device Regulations 3
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
I Technical Support - Medical Device Software Life Cicle IEC 62304 - Medical Device Software Life Cycle Processes 2
rob73 Technical File Information on Moulded Parts of a Medical Device EU Medical Device Regulations 5
I Technical Agreement Template for a Class II Medical Device in EU wanted EU Medical Device Regulations 3
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
S Medical Device Technical Files (Class IIa & IIb) ? Design Development Documentation EU Medical Device Regulations 7
M Documentation of OEM Device - Technical File for a Class IIa Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 4
D Medical Device Packaging - Trying to learn Technical files EU Medical Device Regulations 4
S Standards used for Medical Device MDD Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 25
S Requirements for Updating a Medical Device Technical File EU Medical Device Regulations 13
B Technical Reports - Class 2 medical device design and manufacturing Design and Development of Products and Processes 14
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
M Medical Device Marketing Material - Control of Social Media 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Ed Panek Make sure you hire competent QA RA Folks before making a "Medical Device." Coffee Break and Water Cooler Discussions 1
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 4
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
B Reprocessing of an accessory for a medical device EU Medical Device Regulations 4
A Class 1 medical device - Thailand Other Medical Device Regulations World-Wide 0
P Interchangeable/alternative parts in BOM (medical device) Manufacturing and Related Processes 4
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
J Shoe Covers - medical device class I EU Medical Device Regulations 3
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
J Medical device repairs (to upholstery) Manufacturing and Related Processes 4

Similar threads

Top Bottom