Does anyone know of a short course, seminar or webinar offered covering topics related to ISO 10993, biocompatibility and/or cytotoxicity? Any and all references are welcome.

Thanks in advance,

Erika

I don't know of any standards body or educational organization that offers webinars or other training on ISO 10993 topics. ISO 10993 effectively has prerequisites, i.e. some level of biological, chemical and clinical knowledge, that probably are hard to manage from an effective-webinar-design perspective.

Some of the larger testing and evaluation businesses, such as NAMSA, Toxicon and Intertek-SEMKO, offer webinars designed to inform you of why you should use their ISO 10993 lab services, and their regulatory product evaluation in general. That of course isn't quite what you're asking for.

In the US, AAMI probably would be the most likely of the standards organizations to offer an ISO 10993 training program. I checked their programs over the past year or so, though, and I didn't see anything.

You can get a fairly good understanding of which ISO 10993 sections may need to be qualified for a particular new product based on its intended use by reviewing FDA guidance G95-1. Once you're there, my perspective is that it's reasonable to hire one of the experienced testing labs with ISO 10993 certifications, discuss with them the particular tests you think you need based on G95-1, tell them you need a GLP-qualified report, provide them with the requisite samples and let them handle it.

Does anyone know of a short course, seminar or webinar offered covering topics related to ISO 10993, biocompatibility and/or cytotoxicity? Any and all references are welcome.

Thanks in advance,

Erika


Welcome to the Cove, Erika :bigwave:

You could check with QServe Group (http://qservegroup.com/cms/item/213) or Blended Learning Solutions (http://www.knowledgeexcellence.com/blended-tap-solutions-technical-and-regulatory.php) for training on ISO 10993

Disclaimer - I do not have any connections to these organizations and have provided purely for informational purposes.

Thank you for your suggestions. I'll definitely check them out. I've come across the webinars offered by testing labs and agree that they are essentially just very expensive infomercials for those labs' services. So far, AAMI and Qserve Group haven't been very fruitful either but I will continue monitoring their calendars in case they offer such events in the future.

On an slight tangent, I was wondering if you find that the EU is more concerned with biocompatibility than the US? I've found some very relevant training opportunities in Europe such as the Medical Device Clinical Congress hosted by Informa Life Sciences but I can't get approval for international travel to attend the events.:(

I was wondering if you find that the EU is more concerned with biocompatibility than the US?

In my experience, the opposite is true.

The FDA's regulatory stance on a broad range of contamination-control and sterility-maintenance equipment covers, for instance (in FDA terms, Product Codes MMP, IYO, and KKX to some extent) is more rigorous than that of the EU via 13485 and MDD.

The FDA requires a 510(k) process for such devices, including laboratory determination of materials biocompatibility per 10993. Evaluation of the submitted information is by subject matter experts. The EU's requirement for Class I and I-s devices, including such equipment covers, usually does not provide for a comparable technically-qualified review.

Biocompatibility data of course normally should be included in a product-family Technical File if the product may have patient or user contact. I know from direct experience, though, that ISO auditors sometimes provide only a cursory review of such Technical Files, primarily focusing on their existence and not on the scientific conclusions of the 10993 evaluations.

Perhaps those with experience in higher device classes might reach opposite conclusions.

Are you really worried just about biocompatibility or with biological safety evaluation? Although a lot of people think they´re the same thing, they´re not (biocompatibility is one of the the aspects of biological safety evaluation). This is important because legislations, such as CE mark, are concerned with biological safety evaluation, not only with it´s biocompatibility aspect.

Anyway, myself think that "biocompatibility" would normally not be a course subject (unless for some kind introductory course - i have a chapter on biocompatibility on my medical device design training). But, i´ve found some time ago that a lot of manufacturers have a real difficult time (at least in Brazil) in understanding biological safety evaluation anjd also in understanding biocompatibility. So i´m developing a training on this, based for example on the book "Safety Evaluation in the Development of Medical Devices and Combination Products", by Shayne C. Gad, and other reliable sources.