Medical Device Design finalization testing

#1
We are doing product development for a patent-protected weak link solution which will prevent accidental dislodgement of IV tubes for patients receiving IV therapy. We have Prototype and are at the product design finalization stage and are looking for Design testing requirements. Can someone please let me know the Europe based companies which help us in coming up with the plan within time and in a cost-efficient manner. We are confused with sample size requirement of the test as well.

Thanks.
 
Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#2
Eurofins is the only one I can think of. I have never worked with them, so I can't say whether they are good or bad.

It sounds like you need more help than just that though. Have you documented your customer and regulatory requirements? This information determines the testing requirements. How is your design history file coming along?
 
#3
Eurofins is the only one I can think of. I have never worked with them, so I can't say whether they are good or bad.

It sounds like you need more help than just that though. Have you documented your customer and regulatory requirements? This information determines the testing requirements. How is your design history file coming along?
We are documeting the customer and regulatory requirements. Thanks for your response.
 
Thread starter Similar threads Forum Replies Date
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0
M Medical Device Design Control Auditor Recommentations General Auditing Discussions 19
R Medical Device Design verification sample prototype Other Medical Device and Orthopedic Related Topics 14
L Managing design projects: New Medical Device Project or Change Design and Development of Products and Processes 1
P Software requirement and design specifications - Medical device contains both hardware and software IEC 62304 - Medical Device Software Life Cycle Processes 2
L Software Medical Device - 7.3.8 - Design and Development Transfer ISO 13485:2016 - Medical Device Quality Management Systems 4
I Design & Development, Research and Innovation in the Medical Device framework ISO 13485:2016 - Medical Device Quality Management Systems 3
3 Brasil: OEM Medical Device Business - Product Design Customization Other Medical Device Regulations World-Wide 6
G Design Philosophy - Iran Medical Device Registration Other Medical Device Regulations World-Wide 7
Q Medical Device Design & Development Plan Template wanted Document Control Systems, Procedures, Forms and Templates 1
Q Looking for documents relating to Medical Device Design Changes Document Control Systems, Procedures, Forms and Templates 5
A Sample document on design and development activities plan for a medical device Other Medical Device Regulations World-Wide 1
L Medical Device New Product Design & Development- How long does this process take you? Other Medical Device and Orthopedic Related Topics 1
L Medical Device Manufacturing Equipment Design Other Medical Device Related Standards 2
M Design Inputs - Final Medical Device Specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Class II Medical Device Design Control Non Conformance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Medical Device Service Records linked to DHR (Design History Record)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A DHF (Design History File) for a Legacy Product (Class iii Medical Device) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
G Medical Device Company - Design Only Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Importance of Medical Device Accessory Design Controls Other US Medical Device Regulations 4
H Medical Device Design Control Requirements (820.30) on Existing Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R Medical Device Software Segregation and Detailed Design IEC 62304 - Medical Device Software Life Cycle Processes 10
A Medical Device Electronic Systems Design - Points to be cleared EU Medical Device Regulations 2
A Design Company - CE Mark for a Medical Device Class 2A , Annex VI & Annex VII EU Medical Device Regulations 12
D Class I and Class II Medical Device Accessory Design Control Requirements US Food and Drug Administration (FDA) 3
T 21 CFR Part 820.30 Design Controls for Class 1 Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
K Medical Device Design Validation vs Clinical Evaluation ISO 13485:2016 - Medical Device Quality Management Systems 5
L When does Medical Device New Product R&D stop and Design start? Design and Development of Products and Processes 6
A Medical Device DHF (Design History File) - One per Design Change? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
L Creating DHF (Design History File) for Medical Device Systems Design and Development of Products and Processes 8
A How to do Medical Device Design Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
B ISO 13485 Class I Medical Device Design Exclusion ISO 13485:2016 - Medical Device Quality Management Systems 10
U Medical Device Design Review Records Requirements Design and Development of Products and Processes 16
A Taguchi Inner and Outer Array Design for Medical Device Testing Quality Tools, Improvement and Analysis 1
J How do I qualify a Label Design for Medical Device Design and Development of Products and Processes 4
D Medical Device Design Verification and Validation Differences 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
J Class II Medical Device Design Revision Controls ISO 13485:2016 - Medical Device Quality Management Systems 7
C At what stage does Design Control play a role in Medical Device Development ISO 13485:2016 - Medical Device Quality Management Systems 2
J What things go in Design Control Documentation for a 510k of Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Design Control & Rapid Prototyping - Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N Medical Device Design and Development Plan Procedures help wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Ajit Basrur Design Controls for medical device exported from China China Medical Device Regulations 5
S Medical Device Design Verification and Validation - info Other Medical Device and Orthopedic Related Topics 1
T Medical Device Design Quality Plan Design and Development of Products and Processes 6
D Design Verification for special 510(k) - Size modification to an existing medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
SteveK Medical Device Technical Files (Class IIa & IIb) ? Design Development Documentation EU Medical Device Regulations 7
N Design and Development Plan for a Medical Device - Template needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
A Medical Device Design Verification Testing - Is ISO 62366:2008 what I'm looking for? IEC 62366 - Medical Device Usability Engineering 16
Similar threads


















































Top Bottom