SBS - The best value in QMS software

Clinical Evaluation - Is this an ISO 13485:2016 requirement?

S

ShRam

Starting to get Involved
#1
#1
Hi,

I need some clarity in Clause 7.3.7- Design and Development Validation.

This clause briefs, "As part of design and development validation, the organization shall perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements".

Is clinical evaluation, a QMS requirement? Does this mean QMS auditors will also look for Clinical Evaluation Report even though there is no product certification?

Kindly clarify this.

Thanks in Advance.
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
The key phrase is "in accordance with applicable regulatory requirements." The QMS requirement is to perform a clinical evaluation wherever there is an applicable regulatory requirement to do so, and an auditor should look for an associated report where the applicable regulatory requirements prescribe such a report.
 
Watchcat

Watchcat

Trusted Information Resource
#3
#3
Ronen E said:
The QMS requirement is to perform a clinical evaluation wherever there is an applicable regulatory requirement to do so.
Click to expand...
Isn't that redundant? If the regulations require one, then the standard doesn't need to require one. If the regulations don't require one then the standard doesn't either. I'm not clear on what is accomplished by the inclusion of this statement in the standard.
 
John Broomfield

John Broomfield

Staff member
Super Moderator
#4
#4
This clause refers the organization to the regs for the method of validation not whether device’s design must be validated which of course it must.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#5
#5
Watchcat said:
Isn't that redundant? If the regulations require one, then the standard doesn't need to require one. If the regulations don't require one then the standard doesn't either. I'm not clear on what is accomplished by the inclusion of this statement in the standard.
Click to expand...
When published standards are written in the most efficient way (i.e. not pointing out anything otherwise deductible) they might end up being misunderstood and mis-implemented. Decades of experience have provided plenty of examples, if one is that curious.
Technically, ISO 13485 could have sufficed with a single sentence - "Just do what the applicable (damn) regulations say!" - to cover the entire regulatory angle.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D What Standards can be used for Clinical Evaluation besides ISO 14155? ISO 13485:2016 - Medical Device Quality Management Systems 9
M Clinical Evaluation Benchmark vs. Equivalent EU Medical Device Regulations 2
S Australia TGA Clinical Evaluation Report (CER) Other Medical Device Regulations World-Wide 0
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
dgrainger Informational MDCG 2020:13 - Clinical evaluation assessment report template EU Medical Device Regulations 0
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 6
M Clinical Evaluation Plan vs. PMCF Plan EU Medical Device Regulations 21
M Can someone share a scrubbed version of Clinical Evaluation Plan (CEP) EU Medical Device Regulations 4
S EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean? EU Medical Device Regulations 13
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
M Informational How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities Medical Device and FDA Regulations and Standards News 0
T EU MDR Article 61- Clinical Evaluation EU Medical Device Regulations 2
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
D Clinical Evaluation Report - Consultant Recommendations Consultants and Consulting 9
M CER (Clinical Evaluation Reports) updates - Product Codes EU Medical Device Regulations 2
A Medical device CER (clinical evaluation report) training/seminar services EU Medical Device Regulations 2
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
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
TheMightyWife Clinical Evaluation MEDDEV 2.7.1 Rev 4 demonstration of equivalence EU Medical Device Regulations 6
C How frequent to conduct Clinical / Performance Evaluation? CE Marking (Conformité Européene) / CB Scheme 4
H Addressing of Undesirable side-effects, harms, risks and side-effects in clinical evaluation report (CER) EU Medical Device Regulations 12
W Literature used in the clinical evaluation ISO 13485:2016 - Medical Device Quality Management Systems 4
S Medical device CER (clinical evaluation report) according to MDR EU Medical Device Regulations 19
M SOPs, Plans and Report templates for Clinical Evaluation of EU MDR Other Medical Device Related Standards 11
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
S Clinical evaluation for a class IIa medical device - EU MDR Requirements EU Medical Device Regulations 3
TheMightyWife Copyright for articles used in CER (Clinical Evaluation Report) EU Medical Device Regulations 16
Q Evidence of precautions (clinical evaluation report, risk management report) EU Medical Device Regulations 6
Rincewind Clinical Evaluation of very low risk medical devices EU Medical Device Regulations 3
SK13485 Can a literature alone be used for the purpose of Clinical Evaluation of a device? EU Medical Device Regulations 6
R Scope and plan of the clinical Evaluation CE Marking (Conformité Européene) / CB Scheme 3
M MDR Clinical Evaluation & investigation (SUMMARY of changes) EU Medical Device Regulations 2
R Clinical evaluation Meddev (2.7.1 revision 4) - Example or Template EU Medical Device Regulations 4
M Clinical Evaluation - MEDDEV 2.7/1 rev4 - Literature route Other Medical Device Related Standards 2
C Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 CE Marking (Conformité Européene) / CB Scheme 3
Q Sample of the MEDDEV 2.7.1 rev 4 Clinical Evaluation Report wanted Document Control Systems, Procedures, Forms and Templates 15
Sam Lazzara Clinical Evaluation MEDDEV Guidelines SmackDown - 2017 EU Medical Device Regulations 3
L Clinical Evaluation Report Updating Procedure Other Medical Device Related Standards 5
R Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 Other Medical Device and Orthopedic Related Topics 1
E CER (Clinical Evaluation Report) MEDDEV Version 4 Template wanted CE Marking (Conformité Européene) / CB Scheme 5
R Clinical Evaluation according to MEDDEV 2.7.1 (Rev 4) - seeking template ISO 13485:2016 - Medical Device Quality Management Systems 6
Z Labeling Requirements for Free Samples supporting Clinical Evaluation EU Medical Device Regulations 2
Gamula CFDA Clinical Evaluation Report (China) China Medical Device Regulations 4
shimonv CFDA Technical Guidelines for Clinical Evaluation on Medical Devices (English) China Medical Device Regulations 8
E Clinical Evaluation of IVD Medical Devices CE Marking (Conformité Européene) / CB Scheme 8
S Clinical evaluation standard operating procedure / SOP for medical devices Document Control Systems, Procedures, Forms and Templates 1
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Document Control Systems, Procedures, Forms and Templates 11
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Imported Legacy Blogs 1

Similar threads

Top Bottom