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.
 
Introducing Process Improvement to New Employees
Elsmar Forum Sponsor
S

Seekingknowledgee

Involved In Discussions
#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
P Looking to outsource Internal Audit - MDSAP competent auditor needed Other Medical Device Regulations World-Wide 9
Q Measurement Equipment Revocation - Looking for a Disposal Form with Risk Assessment IATF 16949 - Automotive Quality Systems Standard 10
B Looking for SSCP file of IVD devices EU Medical Device Regulations 7
M Looking for a copy of ISO 10651 Hospitals, Clinics & other Health Care Providers 6
Azaarus Looking for important points regarding First Piece Inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
L Looking for Control Plan and FMEA Stamping process FMEA and Control Plans 2
Q Looking for a 5S tracking database Problem Solving, Root Cause Fault and Failure Analysis 4
N Looking for a recommendation for an EU MDR Importer EU Medical Device Regulations 1
K Technical file for MHRA - looking for assistance with self declaration Class I device CE Marking (Conformité Européene) / CB Scheme 8
J Looking for partners Paid Consulting, Training and Services 2
bryan willemot Looking for an Approved vendors list template Document Control Systems, Procedures, Forms and Templates 11
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
M Data Protection and Privacy Policy - looking for a template/example EU Medical Device Regulations 1
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
blackholequasar Looking into Nadcap for the first time AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
S We are looking for EU authorised Representative for both Class I and Class IIb devices EU Medical Device Regulations 7
K Looking for a job as Quality Engineer Career and Occupation Discussions 3
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
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 4
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
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
J Looking for a EU MDR Gap Analysis template EU Medical Device Regulations 6
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 1
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 11
C Looking for source of silicone contamination in ISO Class 8 Cleanroom Other Medical Device Related Standards 2

Similar threads

Top Bottom