Assembling technical file for a medical device

#1
HI all

I work for a health care organization, that undertakes point of care manufacturing to produce devices that will enhance post operative patient health. We are currently establishing a QMS. We also are trying to understand what needs to go into a technical file for submission to TGA. Can someone point me to a good resource that we can use? Although we managed to find the file structure, there aren't any guidance text for what is expected in each folder. Any advice and assistance is most appreciated.

Regards
Rani
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
R Assembling a Cross Functional Root Cause Analysis Team Problem Solving, Root Cause Fault and Failure Analysis 4
K Assembling an ISO Steering Team ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Newbie, easy to follow guide for organizing/assembling very first PPAP booklet APQP and PPAP 3
K Fastener bolt torque Best Practices - Assembling electronics components Manufacturing and Related Processes 7
C Six Sigma Defects per Unit (DPU) - Manufacture Of Computer And Audio Parts Assembling Six Sigma 2
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
Pmarszal Technical File - Critical Supplier List Questions CE Marking (Conformité Européene) / CB Scheme 2
Z How to keep up with changes on applicable technical standards (EU MDR)? EU Medical Device Regulations 6
D Does the DoC require a technical documentation version? ISO 13485:2016 - Medical Device Quality Management Systems 1
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 1
E Discussion: How do you split up your Technical Documentation? EU Medical Device Regulations 4
B Technical Documentation for a medical device accessory Medical Device and FDA Regulations and Standards News 6
I Request for information regarding remote medical monitoring software (its technical documentation and the IUD system) IEC 62304 - Medical Device Software Life Cycle Processes 2
G Technical documentation for UKCA UK Medical Device Regulations 4
A Technical Documentation => Responsibilities when signing documents ISO 13485:2016 - Medical Device Quality Management Systems 7
A Update of Technical Documentation EU Medical Device Regulations 3
G Similarities between format of technical file for CE and ASEAN common submission dossier template (CSDT) CE Marking (Conformité Européene) / CB Scheme 2
V How many hrs does it take to create a Technical File (TD)? EU Medical Device Regulations 4
A Updating Technical Documentation regularly => Leaner Release Advice EU Medical Device Regulations 2
P Updates to Technical Documentation EU Medical Device Regulations 7
Q Structure Technical File for a system EU Medical Device Regulations 0
S Documents belonging to Technical documentation to be stored in one file or spread in the QM system? EU Medical Device Regulations 9
Fjalar ISO 20417:2021: Technical Data (6.6.4 c) Other Medical Device Related Standards 0
L ISO/IEC 20000-6 Technical Areas IT (Information Technology) Service Management 2
D Technical Standard aggregator company suggestions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Biggest issues when producing MDR compliant Technical Files / DD EU Medical Device Regulations 4
J How many hours for a NB to review Technical Documentation? EU Medical Device Regulations 6
J Technical Documentation as per MDR / subpoint 6.1 EU Medical Device Regulations 3
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
A Technical documentation ce marking pippete tips CE Marking (Conformité Européene) / CB Scheme 0
B MDR Technical Structure EU Medical Device Regulations 3
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 4
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
I "Usability" for technical documentation EU Medical Device Regulations 1
E Technical documentation for IVDD General/ other CE Marking (Conformité Européene) / CB Scheme 3
C European Technical File for registration in Australia CE Marking (Conformité Européene) / CB Scheme 5
K Technical file for MHRA - looking for assistance with self declaration Class I device CE Marking (Conformité Européene) / CB Scheme 8
H MD Technical Documentation and SALES possibility EU Medical Device Regulations 0
O Soft and technical skills for a VP of Quality Career and Occupation Discussions 1
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 5
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
R MDR & depth of technical files review by NB's EU Medical Device Regulations 18
J Saudi Arabia Technical File Requirements Other Medical Device Regulations World-Wide 1
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 2
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 6
Al Rosen Technical File - Updating Applied Standards EU Medical Device Regulations 4

Similar threads

Top Bottom