Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR

pashah

pashah

Registered
#1
#1
Hi all,

We have created the templates for the clinical evaluation plan and report already; but we are struggling with the SOP/Procedure for clinical evaluation as part of a Design and Development procedure.

Has anyone already implemented such a procedure? If there is some sort of a template; it would be very useful.

Thanks in advance.
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
S

Seekingknowledgee

Starting to get Involved
#2
#2
pashah said:
Hi all,

We have created the templates for the clinical evaluation plan and report already; but we are struggling with the SOP/Procedure for clinical evaluation as part of a Design and Development procedure.

Has anyone already implemented such a procedure? If there is some sort of a template; it would be very useful.

Thanks in advance.
Click to expand...
Hi ,

I am looking for templates of Eu MDR sops. Did you get any?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
mihzago Looking for an Australian/ NZ Sponsor Other Medical Device Regulations World-Wide 0
S New Foreign Exporter Looking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
N Looking to Impress - New Job - Advice, Thoughts, Comments Welcome Career and Occupation Discussions 23
Y We are Looking for EASA LOA TYPE 1 experienced software developer Job Openings, Consulting and Employment Opportunities 0
J Looking for a training organization that can provide in house DFMEA training FMEA and Control Plans 4
A Looking for a third party to calibrate our measure equipment - South Carolina General Measurement Device and Calibration Topics 6
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
N Looking for Gamma sterilization facility in China ISO 13485:2016 - Medical Device Quality Management Systems 4
A 5 x 5 Risk Matrix - Looking for a good example Manufacturing and Related Processes 2
M Looking for a Presentation on Design for Excellence (DfX) Manufacturing and Related Processes 2
V ISO 50001 - looking for a generic checklist Various Other Specifications, Standards, and related Requirements 5
J Looking for a EU MDR Gap Analysis template EU Medical Device Regulations 4
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 0
A New to QC, looking for resources Problem Solving, Root Cause Fault and Failure Analysis 3
bryan willemot Looking for a certified test report for aerospace parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
K I’m looking for a square probe for my linear height gauge Manufacturing and Related Processes 1
C Looking for China Good manufacturing practice China Medical Device Regulations 1
M Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At? EU Medical Device Regulations 7
DuncanGibbons Looking for example aerospace part CAD files to be used for a case study Career and Occupation Discussions 2
A We're currently looking for any studies performed on various PPE materials Qualification and Validation (including 21 CFR Part 11) 1
C Looking for APQP Training recommendations preferably in the aerospace industry APQP and PPAP 2
M Looking for third party reviewers for FDA submissions US Food and Drug Administration (FDA) 2
C Looking for simple Software Validation IQ templates. Qualification and Validation (including 21 CFR Part 11) 4
H Looking for Tips on finding an IATF consultant Consultants and Consulting 6
W My company is looking to start a materials testing lab that conforms to ISO17025:2017 ISO 17025 related Discussions 3
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
bryan willemot Looking for a good CoC to put with my certification sheets when we send parts Document Control Systems, Procedures, Forms and Templates 1
L I'm looking for Translation Procedure Guide MEDDEV 2.5/5 Rev.2 (NOT Rev.3) CE Marking (Conformité Européene) / CB Scheme 0
K Looking for a good Six Sigma book Six Sigma 7
G Looking to move to an electronic QMS software Software Quality Assurance 10
C Looking for source of silicone contamination in ISO Class 8 Cleanroom Other Medical Device Related Standards 2
F Looking for a Japan MAH recommendation that is not too expensive Japan Medical Device Regulations 4
P Looking for Risk Assessment Template - Not necessarily Asset based IEC 27001 - Information Security Management Systems (ISMS) 1
S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
JT3M Looking for FMEA plastic injection molding FMEA and Control Plans 8
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
N Looking for input on the attached Process / IATF 16949 Clause Matrix IATF 16949 - Automotive Quality Systems Standard 4
Ajit Basrur Looking for a Design Transfer Checklist 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N I am looking at two Registrars Registrars and Notified Bodies 18
P ISO 14001 - Looking for a Gap Analysis Template ISO 14001:2015 Specific Discussions 3
E Usability Process - Looking for a template (IEC 62366) IEC 62366 - Medical Device Usability Engineering 1
S What are you looking for in an automated quality management system? Quality Assurance and Compliance Software Tools and Solutions 8
S Usability procedure - looking for a template IEC 62366 - Medical Device Usability Engineering 3
D Looking for PowerPoint presentation for ISO 17025:2017 ISO 17025 related Discussions 1
A IATF 16949 - 9.2.2.1 Internal Audit Programme - looking for example IATF 16949 - Automotive Quality Systems Standard 5
Q ISO 19011 - Looking for a Presentation Material Other ISO and International Standards and European Regulations 6
A Looking to become an IATF 16949:2016 Certified Auditor IATF 16949 - Automotive Quality Systems Standard 7
S Looking for an example of a medical device file ISO 13485:2016 - Medical Device Quality Management Systems 1
C Looking for RED ESD Bags that preferably say NON-CONFORMING Manufacturing and Related Processes 5

Similar threads

Top Bottom