GD210 Annex A in excel format?

R

rob_heg

#1
Hi,
We have an internal audit coming up, and last year we used the GD210 as a guide. The internal auditor just wrote notes on the size margin of the GD210 printout. This became our record of evidence that the IA was complete.

We were certified last year for the first time to 13485 with CMDCAS, but still pretty noobish to best practices for doing IA. It seems that it would be nice if the GD210 Annex was available in an excel format, and we could add columns like Yes, No, Ref Doc, Notes, etc that the auditor could fill out on the fly instead of scanning everything at the end so we can have an electronic copy.

Does anyone know if such xls is available? I have had no luck searching google and elsmar. I could copy/paste PDF text into the cells, but that would take much time that I don't have.

I appreciate your help.

Rob
 
Elsmar Forum Sponsor

DannyK

Trusted Information Resource
#4
There are some registrars that have the Canadian requirements incorporated into a checklist but I do not believe they would want to offer it to the general public.
 
R

rob_heg

#5
I am going to create one then. I can attach when done if anyone thinks it would help them out as well.
 
Thread starter Similar threads Forum Replies Date
A MDR ANNEX XI part A or Part B EU Medical Device Regulations 0
S EU MDR Annex I Chapter III 23.4 z EU Medical Device Regulations 2
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
K Section 13.6 Annex 1 MDD 93/42/EEC for Glove EU Medical Device Regulations 0
D Is PMCF really a continuous activity per Annex XIV,Part B? EU Medical Device Regulations 5
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
L EN 62368 (In an Annex - M.4.2.1) Secondary Lithium Battery Charging Safeguards CE Marking (Conformité Européene) / CB Scheme 2
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
K Applicability of Cybersecurity EU MDR 2017/745 Annex 1 23.4(ab), 14.2(d) CE Marking (Conformité Européene) / CB Scheme 3
K Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1 CE Marking (Conformité Européene) / CB Scheme 0
I IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities? CE Marking (Conformité Européene) / CB Scheme 2
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 4
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 4
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
S EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean? EU Medical Device Regulations 16
K Annex XVI Device Transition Timeline under the MDR EU Medical Device Regulations 2
M EU MDR - Annex II 3b - What documents fall under this requirement? EU Medical Device Regulations 3
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state EU Medical Device Regulations 7
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
Z 21 CFR and Annex 11 mapping document Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
A EU-MDR Annex I Requirement 10.1(d) EU Medical Device Regulations 3
T Post-Market Surveillance Plan - Requirements outlined in Annex III (1.1b) EU Medical Device Regulations 2
D Applicable MDR Annex's for Class IIa Medical Devices EU Medical Device Regulations 0
J MEDDEV 2.12/1's new MIR & IMDRF terms & codes (IMDRF Annex) EU Medical Device Regulations 1
M MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture. EU Medical Device Regulations 1
D Example for Accessories of "Annex XVI non-medical devices" and how to classify it now with respect ot EU MDR Other Medical Device Regulations World-Wide 1
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
H Critical Supplier Agreement acc. to NBOG 2010-1 Annex II EU Medical Device Regulations 10
L EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content EU Medical Device Regulations 5
T EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) EU Medical Device Regulations 0
M Annex II - Technical Documentation. V&V, Performance and Safety EU Medical Device Regulations 3
S MDR Annex II Design & Manufacturing info - 'Adjuvants' definition EU Medical Device Regulations 3
J IVDR and MDR ANNEX I Requirements Template EU Medical Device Regulations 7
M Annex I - General Safety and Performance Requirements. Precise identity - how provided EU Medical Device Regulations 6
S Class II Medical Device Conformity Assessment Route according to Annex V only CE Marking (Conformité Européene) / CB Scheme 7
F IMDRF opened a Consultation on Annex E & F and the link to ISO 14971 ISO 14971 - Medical Device Risk Management 4
Douglas E. Purdy ISO/IEC 17025:2017 Clause 8 & Annex B ISO 17025 related Discussions 9
W EU GMP Annex XI - What is an "appropriate QMS"? Other Medical Device Related Standards 2
C Annex II EU MDR gap analysis EU Medical Device Regulations 7
W MDR Annex I chapter 23.2 (q) - Information required on the label EU Medical Device Regulations 17
I Formula in the Annex of IEC 61000-4-3 - How is k=7 determined? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
H Meaning of Annex II, excluding point Clause 4 conformity CE Marking (Conformité Européene) / CB Scheme 4
Paul Simpson Informational The role of Annex SL - High Level Structure of ISO MSS's - Revision Update February 2019 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
N What should be included in the supply contract - Annex 2 list B IVD ISO 13485:2016 - Medical Device Quality Management Systems 6
R Background of Annex X section 1.1d of MDD 93/42/EEC EU Medical Device Regulations 74

Similar threads

Top Bottom