Hello Ming,
You might want to consider contacting a company who work with medical device companies for functional testing especially looking at a combination product, assuming like a needle-injection or auto-injection device. To answer your question, there is nothing specific though a testing laboratory should be ISO 17025 certified which is the certification for testing laboratories. They may also have other types of qualification or testing parameters based on the specific device type to review.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Apr-2021 01:45
From: Marc Klinkhamer
Subject: Registration and certification requirement for device functional testing at the contract lab
Dear Ming,
The MDR refers to Directive 2004/10/EC of the European Parliament and of the Council, which is re. GLP and testing of chemical substances. ISO17025 or other relevant GLP certification would be acceptable to.
Best regards,
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Marc Klinkhamer
Netherlands
marc.klinkhamer@gmail.com
Original Message:
Sent: 08-Apr-2021 18:27
From: Ming Aquila
Subject: Registration and certification requirement for device functional testing at the contract lab
Hi, All:
Our company is planning to source several device functional tests (of a combination product) to a "pharmaceutical" centric contract testing laboratory. We are currently using the same lab for Drug Product analytical testing. Since now expanding its capabilities to perform device testing, is there specific regulation or ISO standard they need to be compliant with? Thank you so much for your help. Ming