Evalaution of the On Market Device to a Revised Standard

QE

Quite Involved in Discussions
#1
Hello All -

I am presently in the process of evaluation of a device that is on market to meet a standard as the regulatory associate wants this as an evidence to complete a EU submission for recertification.

The standards I am evaluating is ISO10555-1, ISO594-1, ISO594-2 and ISO11070.

Can some one from this group please provide me an example of a document that can help me perform this Gap Assessment in an easy and readable format.

Thank you
QE
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#3
I guess I'm a little confused about your question.

You have the standards, the standards define the requirements / expectations, you assess compliance against those requirements / expectations (to identify the gaps), and take whatever actions necessary to close the gaps. Can you be a bit more specific?
 
Likes: QE

QE

Quite Involved in Discussions
#4
Yes, what you said is exactly true. But the presentation of it is challenging. I was wondering if you can advise on a standard tool or a form to do so.

Thanks
QE

I guess I'm a little confused about your question.

You have the standards, the standards define the requirements / expectations, you assess compliance against those requirements / expectations (to identify the gaps), and take whatever actions necessary to close the gaps. Can you be a bit more specific?
 

yodon

Staff member
Super Moderator
#5
Ah, now I understand.

I don't know of any specific tools or forms. You might search the post attachments for "audit forms" or similar. Effectively, that's what you're doing. Basically, just a 3-column table: what the requirement is, what you're currently doing, and then your assessment of compliance.
 
Thread starter Similar threads Forum Replies Date
M EU MDR - Labilities when a device is discontinued from the Market EU Medical Device Regulations 1
A Packaging device with accessories already on the market Other Medical Device Regulations World-Wide 0
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
F When to market and distribute device in EU? EU Medical Device Regulations 3
N Post Market Surveillance Package Example Wanted ISO 13485:2016 - Medical Device Quality Management Systems 1
T Modification of a product on the market EU Medical Device Regulations 2
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
K Product (Device) Life cycle - Product Life AFTER the Post Market Phase Medical Device and FDA Regulations and Standards News 3
M Post Market Surveillance for Class II Medical Devices Medical Device and FDA Regulations and Standards News 2
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
H Post-market surveillance strategy EU Medical Device Regulations 1
B Procedures for Complaint Handling and Post Market Surveillance EU Medical Device Regulations 7
A Post-market clinical followup studies (PMCF) EU Medical Device Regulations 16
M Informational Creating a post market surveillance (PMS) system for medical devices – Part 1 Medical Device and FDA Regulations and Standards News 7
E Post Market Surveillance Standard Various Other Specifications, Standards, and related Requirements 4
N When is "placing on the market"? MDD certified medical devices EU Medical Device Regulations 32
K EU MDD Class I Device market access / certification after 26th May 2020 EU Medical Device Regulations 9
T Post-Market Surveillance Plan - Requirements outlined in Annex III (1.1b) EU Medical Device Regulations 2
M Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
Y Post Market Surveillance Indicators and Analysis method EU Medical Device Regulations 1
M Post Market Surveillance Plan Template EU Medical Device Regulations 6
F Vietnamese Post-Market Surveillance Requirements for a medical device in Japan Other Medical Device Regulations World-Wide 0
M PMCF (Post Market Clinical Followup)/ PSUR template EU Medical Device Regulations 8
C Shipping Medical Devices to US before pre market clearance US Food and Drug Administration (FDA) 1
M New medical device on the market before MDR EU Medical Device Regulations 12
M Informational The ANSM decides, as a precautionary measure, to withdraw from the market macrotextured breast implants and breast implants with polyurethane-coated s Medical Device and FDA Regulations and Standards News 0
S PMCF (Post Market Clinical Followup): Rationale for Exemption - Software Medical Devices EU Medical Device Regulations 6
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
S Post Market Surveillance and Annual Product Review in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
M Informational TGA – Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices Medical Device and FDA Regulations and Standards News 0
Kuldeep Singh Post Market Clinical Follow up and CE Marking for Class IIb medical X-Ray products CE Marking (Conformité Européene) / CB Scheme 1
M Informational Links to recognized / harmonised / consensus Standards for each market Other Medical Device Related Standards 5
M Entering the Italian Market - Implantable Medical Device EU Medical Device Regulations 1
M Informational EU Review and assessment of market surveillance activities 2014-2016 – Medical devices sector Medical Device and FDA Regulations and Standards News 0
M Medical Device News Health Canada – Consultation: Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
M Medical Device News Joint Action On Market Surveillance Of Medical Devices (JAMS) Releases Progress Update EU Medical Device Regulations 0
M Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management Canada Medical Device Regulations 1
S CE ETA (A2) Audit - CE mark for the european construction market CE Marking (Conformité Européene) / CB Scheme 0
M Medical Device News EU - List of national market surveillance authorities by sector and country EU Medical Device Regulations 0
H Claiming equivalence with the product that was sold earlier in the market but not now EU Medical Device Regulations 1
C Spares Market Supplier - Do we need to follow AS9110 or AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
I IVD prototypes in EU market ISO 13485:2016 - Medical Device Quality Management Systems 2
V Placement of cosmetic products on EU market as medical devices EU Medical Device Regulations 2
W Interesting Discussion PMCF (Post-Market Clinical Followup) vs PMCF studies EU Medical Device Regulations 36
K EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)" EU Medical Device Regulations 2
S An auditor asked for a Post Market Surveillance Report ISO 14971 - Medical Device Risk Management 4
K Class II Medical Device Compatibility Issue - Removal or Market withdrawal? US Food and Drug Administration (FDA) 2
T Proactive / Preventive Post Market Surveillance question ISO 13485:2016 - Medical Device Quality Management Systems 4
N MRA EU-TGA Product Registration to EU Market EU Medical Device Regulations 1

Similar threads

Top Bottom