Medical Device Validation and Pharmaceutical Validation differences?

ifserav

Involved In Discussions
#1
Hi to everibody!
I want to know if is there any difference between the medical device validation and the pharmaceutical process validation?

i know the process are quite different, but i want to know if the equipments need to be qualified, write a protocol and the same methodology.

Thanks a lot

Sergio Ávila
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Speaking strictly from the medical device side...

A device does need to be verified (conforms with requirements) and validated (meets user needs and intended uses). If equipment is used in the V&V activities, it does need to be qualified. There's not really an equivalent for pharma products, I don't think.

Where there is some equivalence is in the production of medical devices. Often times the production processes need to be validated and / or the production equipment needs to be qualified. The management and control of these production processes are, I believe, generally consistent with the process validation requirements on the pharma side.
 
Thread starter Similar threads Forum Replies Date
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
I Medical device Validation/Verification template ISO 13485:2016 - Medical Device Quality Management Systems 1
Z Class 2 medical device - Process Validation - Test sterile or non-sterile units? Qualification and Validation (including 21 CFR Part 11) 4
M Medical Device Process validation, Validation of excel spreadsheets used for process Other Medical Device and Orthopedic Related Topics 4
V Tyvek packaging for Medical device process validation Qualification and Validation (including 21 CFR Part 11) 2
A SOP for software validation of software in medical device IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
I Implantable medical device cleaning validation Other Medical Device Related Standards 3
R Determining Sample Size for Medical Device Component Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
M Example Medical Device Validation Plan and Report wanted CE Marking (Conformité Européene) / CB Scheme 4
N China's CFDA - Medical Device Validation Requirements China Medical Device Regulations 8
P Medical Device Validation Protocols and Reports - Acceptance Criteria Other Medical Device and Orthopedic Related Topics 3
T Validation Plan for a new Class II Medical Device (Critical Care Medical Ventilator) IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A Inspection Protocol Validation for a Medical Device Customer Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
D Medical Device Software Tool Validation - Compilers! IEC 62304 - Medical Device Software Life Cycle Processes 7
N When is Medical Device Software Validation required? ISO 13485:2016 - Medical Device Quality Management Systems 6
R Medical Device Packaging Label Validation Other US Medical Device Regulations 8
JoCam Validation of a change to a CE Marked Medical Device EU Medical Device Regulations 4
A FDA Medical Device Reprocessing Guidance - Validation US Food and Drug Administration (FDA) 6
P Validation of Class I Metal Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
W Process Validation Training - Custom made Medical Device Design and Development of Products and Processes 4
J Mobile Medical Device App Validation Guidance vs. GPSV? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Z IEC 62366 and Medical Device Usability Validation IEC 62366 - Medical Device Usability Engineering 10
E FDA Requirements for Implantable Medical Device Software Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
C Thoughts on validation of Legacy Systems for Medical Device Software EU Medical Device Regulations 2
A ClassIIa Medical Device Software Validation Report Format and Content IEC 62304 - Medical Device Software Life Cycle Processes 5
A Medical Device Software Validation Guidance Software Quality Assurance 3
B Validation of a Pressure Decay Leak Tester for a Medical Device Design and Development of Products and Processes 2
K Medical Device Design Validation vs Clinical Evaluation ISO 13485:2016 - Medical Device Quality Management Systems 5
T Medical Device Software Verification & Validation for Client Specific Configurations Design and Development of Products and Processes 2
S Medical Device Mechanical Test Method Validation Design and Development of Products and Processes 8
suildur Sterilization Validation of a Unique Medical Device Other Medical Device Related Standards 5
L Validation Plan Requirements when moving to a new Plant - Medical Device Industry Qualification and Validation (including 21 CFR Part 11) 19
K Re-validation of Out Sourced Medical Device Sterilization Process ISO 13485:2016 - Medical Device Quality Management Systems 3
A How to do Medical Device Design Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
S Medical Device Software (Firmware) Validation with using IEC62304 IEC 62304 - Medical Device Software Life Cycle Processes 21
A Software Validation Requirements for Class I Active Medical Device EU Medical Device Regulations 4
D Medical Device Design Verification and Validation Differences 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
A Software Validation for Class I - Manufacture of a Part for a Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 9
R Medical Device Inspection Sheets - Excel Spreadsheet Validation US Food and Drug Administration (FDA) 2
T Medical Device Manufacturer Document Control Computer System Validation Qualification and Validation (including 21 CFR Part 11) 4
S 21 CFR 820.75 Process Validation for Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T New Product Validation Plan example or template for a Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Medical Device Software Verification and Validation Results - What is necessary? Software Quality Assurance 4
R Medical Device SPC Software Validation Statistical Analysis Tools, Techniques and SPC 6
Q Medical Device Field Service Performance Inspection Process Validation Qualification and Validation (including 21 CFR Part 11) 1
S Medical Device Design Verification and Validation - info Other Medical Device and Orthopedic Related Topics 1
E ISO 62304 and Validation of Medical Device Software Tools IEC 62304 - Medical Device Software Life Cycle Processes 17
C Teaching Medical Device Regulation and Validation - Course Content ISO 13485:2016 - Medical Device Quality Management Systems 11

Similar threads

Top Bottom