Technical File - Updating Applied Standards

A

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#1
#1
If you make a change to your device do you maintain the applied standard in the list or delete it from the list.
For example: The device originally included a laser positioning system and it has been changed to eliminate it. Do you remove the applicable standard?
 
Paper to QMS ad
Elsmar Forum Sponsor
shimonv

shimonv

Trusted Information Resource
#2
#2
I would say yes, providing you don't have installed system using the obsolete technology. If you do, then I would keep it because some of the test reports in the Technical File probably make reference to the standard.
 
A

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#3
#3
shimonv said:
I would say yes, providing you don't have installed system using the obsolete technology. If you do, then I would keep it because some of the test reports in the Technical File probably make reference to the standard.
Click to expand...
Thank you.
 
Watchcat

Watchcat

Trusted Information Resource
#4
#4
Hi Al, glad to see you are still with us! Does that mean you didn't have COVID-19 or you got through it with relatively mild symptoms?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Requirements for Updating a Medical Device Technical File EU Medical Device Regulations 11
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
M What to be careful about/focus on when doing a Technical File review EU Medical Device Regulations 4
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
G Same intended use devices - Technical file EU Medical Device Regulations 2
F Management of Software version while NB reviews Technical file CE Marking (Conformité Européene) / CB Scheme 7
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
N Technical file requirements class 1 device MDR Other Medical Device Regulations World-Wide 6
O Medical Device Technical File Confidentiality - On site reviews EU Medical Device Regulations 14
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
M Technical File (STED) labelling - When you compile tech files do we have to include all the product labels? EU Medical Device Regulations 2
S MDR Technical File Structure Requirements EU Medical Device Regulations 12
D MDD to MDR - Technical File conversion EU Medical Device Regulations 4
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
TechnicalGuy Technical File Review - Transfer to a new NB EU Medical Device Regulations 3
J One Medical Device, two indications, two classes, one technical file? EU Medical Device Regulations 3
A Technical file requirement for Class IIb medical device CE Marking (Conformité Européene) / CB Scheme 3
D Technical file structure/content requirements for Class IIa devices & new MDR EU Medical Device Regulations 14
J Update Technical File for EU Class IIa Medical Software Products EU Medical Device Regulations 3
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 9
T Technical File - Previous Device Generations EU Medical Device Regulations 2
K Questions on Technical File to show it is current EU Medical Device Regulations 5
Sam Lazzara Expedited, fast-track Notified Body Technical File reviews EU Medical Device Regulations 3
S Question about Australia - TGA and MDSAP - Technical file ISO 13485:2016 - Medical Device Quality Management Systems 3
A Technical File Procedure (for Company) - Example wanted EU Medical Device Regulations 1
C Technical File Assessment from a NB - Clinical Equivalence CE Marking (Conformité Européene) / CB Scheme 6
M Merge Technical File, DMR, and Device File into a single document? Other Medical Device and Orthopedic Related Topics 3
R Technical File Guidance for Preclinical Evaluations EU Medical Device Regulations 12
SteveK On site Technical File Review by our NB EU Medical Device Regulations 3
R ISO13485:2016 Clause 4.2.3 - Changes in Technical File Requirements ISO 13485:2016 - Medical Device Quality Management Systems 18
shimonv Which class I accessory information should be kept in the Technical File EU Medical Device Regulations 6
A Technical File Maintenance - Old generation product EU Medical Device Regulations 4
JoCam Review of Technical File for CE mark EU Medical Device Regulations 6
F Technical File - RoHS2 Technical Documentation RoHS, REACH, ELV, IMDS and Restricted Substances 2
Q Use of standard references in documentation (PRS, Technical File) Document Control Systems, Procedures, Forms and Templates 1
N CE Marking Checklist Technical File Under MRA EU Medical Device Regulations 5
A CE Mark - Maintaining Technical File and Regulatory Assessment CE Marking (Conformité Européene) / CB Scheme 1
O CE TCF (Technical Construction File) Template for LVD/EMC/Pressure Directive CE Marking (Conformité Européene) / CB Scheme 5
M Technical File Locations - Class I and Class IIa Medical Devices EU Medical Device Regulations 3
A Technical Files/Dossier/STED File Maintenance for Notified Body Audiits Other Medical Device Regulations World-Wide 2
D TENS Device (Transcutaneous Electrical Nerve Stimulator) Technical File CE Marking (Conformité Européene) / CB Scheme 4
B Which Department does the Technical File reside? EU Medical Device Regulations 9
Q Class I Technical File reviewed during ISO 13485 Certification Audit by NB CE Marking (Conformité Européene) / CB Scheme 10
F MDD, Technical File, Clinical Evaluation for PACS/DICOM Viewer ISO 13485:2016 - Medical Device Quality Management Systems 2
E When to submit a Technical File for a Class IIb Medical Device EU Medical Device Regulations 3
R Terminology for referring to a product that has an approved Technical File EU Medical Device Regulations 3
N Pls help me with format of CE technical file CE Marking (Conformité Européene) / CB Scheme 8
Q Technical File for Medical Device Accessories CE Marking (Conformité Européene) / CB Scheme 4
Similar threads
Top Bottom