Choosing a laboratory for biocompatibility test

bio_subbu

Super Moderator
#1
Dear Forum users

This is regarding getting biocompatibility testing of devices done from an external laboratory as per ISO 10993. What all the pre-requisites of choosing/ selecting/ qualifying an external laboratory for getting biocompatibility test done, including accreditation to ISO/IEC 17025 or equivalent but not just limited to. Is that a requirement mandatory by regulation (if I would market them to such specific countries, and if so, grateful if you explain such country specific regulation) or it is an added value to our product testing by such reputation?

Thanks and Regards
S. Subramaniam, INDIA
 
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GStough

Staff member
Super Moderator
#3
Dear Forum users

This is regarding getting biocompatibility testing of devices done from an external laboratory as per ISO 10993. What all the pre-requisites of choosing/ selecting/ qualifying an external laboratory for getting biocompatibility test done, including accreditation to ISO/IEC 17025 or equivalent but not just limited to. Is that a requirement mandatory by regulation (if I would market them to such specific countries, and if so, grateful if you explain such country specific regulation) or it is an added value to our product testing by such reputation?

Thanks and Regards
S. Subramaniam, INDIA
I'm not sure if there are specific requirements for choosing an external lab for biocompatibility testing, but we use SATRA (located in the UK) for ours. We chose one that is a "one-stop shop" where we can get the most value from the service for the fees we pay.

There are others, as well. I think NAMSA is one. Perhaps someone else has other suggestions...:bigwave:
 
M

MIREGMGR

#4
EU:

EN ISO 17025 has mandatory applicability to laboratory organizations that provide EN ISO 10993 biocompatibility testing to medical device makers that are MDD compliant. You should consider only labs that can provide a 17025 certificate with appropriate scope for the period of time during which they performed testing for you.

FDA:

Laboratory organizations that provide ISO 10993 biocompatibility testing to medical device makers are at least strongly encouraged to be compliant with Good Laboratory Practices (GLP), 21 CFR 58. You should consider only labs that can certify in their results-report for you that they have conformed to GLP during the testing they performed for that report.

I don't know what requirements apply in China or Russia.

Japan utilizes 10993-based biocompatibility standards, but I don't know what requirements they have for labs.

I believe most if not all other nations will accept EU or FDA biocompatibility testing results, or some combination of the two.
 

bio_subbu

Super Moderator
#5
Thank you so much for your informative post. Recently, I have received a quotation from one of leading laboratory which is being providing the testing services for biocompatibility. The laboratory holding NABL accreditation (NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with ISO/IEC 17025 and ISO 15189:2003 for medical laboratories). But not being followed the FDA regulation 21 CFR Part 58. They quoted for both GLP and Non-GLP studies. For GLP studies, quoted little higher then Non- GLP, I inquired with the respective person about the reason for the difference, and they says that for GLP, In-house quality assurance people will audit for your entire biocompatibility testing process.

I am not interested to go with GLP since they are biased people auditing for the same. So what is your opinion on this?

Regards
S. Subramaniam
 
M

MIREGMGR

#7
I am not interested to go with GLP since they are biased people auditing for the same. So what is your opinion on this?
I understand how you could have a theoretical ethical concern based on that explanation. In my experience such ethical issues are not relevant to the work of a well-selected, reputable lab. Also, I don't think they provided you with a very good explanation of GLP (21 CFR 58).

Generally the point of GLP is to assure the application of a standardized set of conditions and practices so that all testing to a given standard can be regarded as "apples vs. apples", i.e. technically comparable. This greatly simplifies the FDA's scientific workload by allowing them to judge the testing results without first having to conduct a technical review of the testing conditions and practices used in order to determine how those condtions and practices may have affected the results.

I suppose a lab of marginal reputability might do things differently for GLP and non-GLP testing. In my experience, reputable labs generally don't have any significant differences in their actual practices between the two project approaches, but they nonetheless charge more for GLP testing because they must prepare and archivally retain additional records and because some operations and recordkeeping processes must be witnessed and signed-off.

During a 510(k) process I usually ascertain what it will take to smoothly interact with the FDA, as disclosed in various guidance documents, and whenever possible I follow those guidelines. They want GLP, so I deliver GLP.
 
Z

zhang126

#9
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