Is Notification of the Test Laboratory always necessary for Supplier Changes?

michael Cejnar

Involved In Discussions
#11
On a related issue, do Conditions of Acceptability (CoA) always have to be retested for the finished product when replacing a critical part by an equivalent UL recognized part with same CoA?

We are replacing an external PSU in a medical product with an equivalent medical one with same CoA, but NRTL lab wants $3500 to retest CoA for "Minimum: Input test, temperature test, dielectric test and leakage test. More tests depend on the condition of the acceptability of the power supply".

We have isolation transformer, internal battery UPS and 5kV optos which barely require a MOOP form the PSU. Our delta risk analysis thus fails to reveal any way the replacement PSU could produce a different test result for the CoA.

Given the risk analysis mania of IEC60601-1 3rd, is there a place for a risk analysis to reduce the retesting burden?
 
Elsmar Forum Sponsor

Peter Selvey

Staff member
Super Moderator
#12
Hi Michael,

Assuming we are talking about product certification (e.g. UL Mark or any NRTL), the point is that the agency takes responsibility for the basic safety of the equipment and they have to comply with rules of the product certification scheme.

It is probably less about risk management and more simple engineering judgement. The agency might be happy to use your engineering input to decide the tests. For example, if the new power supply is rated/tested for 200W, and your actual use is only 65W, then you could say a temperature rise test would be a waste of time.

Anyway, most likely the biggest cost for them is just the paperwork behind the change, even if no tests are done. And if tests are skipped, they would need to write up justifications which could get knocked back by reviewers, auditors, accreditation agencies etc. It is often it is easier to just to do the test. Power input, leakage current, and some dielectric strength (e.g. mains to earth) are simple tests which it makes sense to do even as a quick spot check. Temperature rise test should be justified, especially if the power supply is external, or used well below ratings.
 

michael Cejnar

Involved In Discussions
#13
Thanks Peter, points well taken.

OK, the difference between a paper approval and testing is not huge: $700 vs $3,500, but it would be nice for customers to know the rules, since quotes are often given by office people and costs accumulate.

For example, if we want to use the new PSU as a spare for older product models, theoretically, we should submit all these earlier models for testing with the new PSU.

As usual, I will see how far I can push.
 
Thread starter Similar threads Forum Replies Date
M IATF16949 Clause 9.1.2.1e - Customer notification related IATF 16949 - Automotive Quality Systems Standard 4
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Competent Authority notification for non-EU manufacturer EU Medical Device Regulations 4
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
P 21 CFR 807.81 When a premarket notification submission is required Other US Medical Device Regulations 0
M Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
D Customer and Company Specific Requirements for notification of Customers of a change in Management or Key Personnel Customer and Company Specific Requirements 3
M Informational US FDA Final guidance – Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions Medical Device and FDA Regulations and Standards News 0
M Informational ANVISA – Notification for Class 1 devices – Resolução da Diretoria Colegiada – RDC nº 270 de 28/02/2019 Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Guidance – Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements Medical Device and FDA Regulations and Standards News 0
supadrai Informational Japan Minor Change Notification Application Form - Found it? Japan Medical Device Regulations 0
C QR Code on Medical Device Packaging and Notification to Notified Body EU Medical Device Regulations 1
S Change Control Form vs. Document Change Notification ISO 13485:2016 - Medical Device Quality Management Systems 3
T External Standard Update Notification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Nemko AS & DQS - Concern over notification as a Medical Device NB Registrars and Notified Bodies 5
E Customer Letter/Notification - Is it a field action? Other US Medical Device Regulations 4
dubrizo IATF 16949 Clause 8.7.1.6 - Customer Notification - Your Inputs Requested IATF 16949 - Automotive Quality Systems Standard 4
N Notification of Changes to a Class I Medical Device - Reporting Requirements EU Medical Device Regulations 4
O Regulatory Notification for IVD IFU Instructions Revision ISO 13485:2016 - Medical Device Quality Management Systems 3
L Notification and submission requirements for medical device material changes Registrars and Notified Bodies 2
T Notification of affected parties of Updated Documented Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J CRB (Certification Registration Body) Notification of Potential Escape AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C Notification to Customers regarding Major Audit Finding IATF 16949 - Automotive Quality Systems Standard 25
GStough Template for Supplier Notification of Audit Supplier Quality Assurance and other Supplier Issues 5
P Acquisition of a company that manufactures a PMA device-FDA notification requriements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
F Notification Procedure for Reimbursement Implants and Invasive Devices in Belgium EU Medical Device Regulations 4
S Audit Notification - Is it a obligation to notify people or just good practice Internal Auditing 18
Stijloor GM (Supplier) and PPAP Requirement 3.1 Customer Notification APQP and PPAP 5
Ajit Basrur FDA: Industry Notification: Furlough Update (8 October 2013) US Food and Drug Administration (FDA) 8
J Process Changes - Customer Notification Requirements APQP and PPAP 12
N Notification Sample Regarding Record Retention ISO 13485:2016 - Medical Device Quality Management Systems 5
O Documenting Processes requiring Customer Notification Misc. Quality Assurance and Business Systems Related Topics 2
A Customer Notification of Change Procedure Quality Manager and Management Related Issues 1
L How to track the NCR (Quality Notification, Services Notification) Nonconformance and Corrective Action 2
A Temporary Change of Manufacturing Site - Notified Body Notification Requirements EU Medical Device Regulations 3
Hershal This morning I received notification that I have my third copyright Coffee Break and Water Cooler Discussions 11
B Control Plan Revision Requirements - Notification of and Approval by Customers FMEA and Control Plans 1
K Customer Notification Requirements - New Packaging Machine for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 1
A Do I need to send notification to Notified body and EC Rep? EU Medical Device Regulations 12
D Customer Notification: PCN - EOL ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Material Grade Change Notification to Brazil ANVISA Other Medical Device Regulations World-Wide 2
M Class I Medical Device - 1st notification and change notification EU Medical Device Regulations 4
S Update on Change Notification for Registered Medical Devices in Singapore Other Medical Device Regulations World-Wide 0
B Process Change Notification (PCN) form to notify our customers of a change Document Control Systems, Procedures, Forms and Templates 3
T Export "Simple Notification" required by the FDA under Section 802 of the Act Other US Medical Device Regulations 3
Q Notification to Registrar Concerning Continuous Dynamics including Restructuring ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Notification To Vendors (Suppliers) of our ISO 9001 Registration Document Control Systems, Procedures, Forms and Templates 6
J Complying with Change Notification Requests - Wholesale Distributor Quality Manager and Management Related Issues 7
P Rework Notification - Is it sufficient to show how we control rework process Manufacturing and Related Processes 1
D Technical File Updates and Notified Body Notification EU Medical Device Regulations 5

Similar threads

Top Bottom