Medical device testing lab/service standard

[pseudoazurin]

Hi All,

What is the general opinion or how the NB or CB point of view of medical device testing lab/service company's quality management system standard? Normally, we would expect GLP or 17025 alike, such that it got traceability to national laboratory scheme e.g. UKAS and with Proficiency Testing, but how about 13485 with certification scope including say microbiological testing?

Thx,

 

[Tidge]

If a lab doesn't make medical devices, I wouldn't expect any sort of certification of compliance to 13485. A medical device manufacturer is free to try to establish some baseline rules during contract negotiations, but I expect that an otherwise accredited lab that doesn't have "13485 certification" wouldn't need to do business with a medical device manufacturer who insisted that the lab get such a certification. Accredited laboratory practices should cover any "related services" in that clause of the scope of 13485.