What are the biocompatibility tests?

An integral part of biological risk assessment, biocompatibility testing assesses the compatibility of medical devices with a biological system. It studies the interaction between the device and the various types of living tissues and cells that are exposed to the device when it comes into contact with patients.

What does namsa stand for?

North American Science Associates, LLC
1970s. 1971. The founding name of ‘Science Associates’ was changed to ‘North American Science Associates, LLC’ (NAMSA); the company moved to its current corporate headquarters in Northwood, Ohio. 1976.

Does namsa test on animals?

By far most common method that NAMSA uses, the guinea pig maximization test, is also the most widely recognized. Typically done with 15 guinea pigs per extract (10 with the test extract, five with the control).

What is in vivo biocompatibility?

Abstract. An in vivo method is described for screening polymeric materials for biocompatibility. The test is based on grading acute and subacute tissue reactions at 7 and 28 days, respectively, following implantation in rats.

How is biocompatibility measured?

Cell culture assays are used to assess the biocompatibility of a material or extract through the use of isolated cells in vitro. These techniques are useful in evaluating the toxicity or irritancy potential of materials and chemicals. They provide an excellent way to screen materials prior to in vivo tests.

Is NAMSA a CRO?

NAMSA is the World’s leading medtech cro offering global end-to-end development services…

How many employees does NAMSA have?

How many Employees does NAMSA have? NAMSA has 200 employees.

Is namsa a good company to work for?

Is NAMSA a good company to work for? NAMSA has an overall rating of 3.2 out of 5, based on over 135 reviews left anonymously by employees.

How many employees does namsa have?

How long does biocompatibility testing take?

Turnaround time for tests can range from three weeks to greater than several months, depending on the specific test data needed. Subchronic or chronic systemic toxicity studies can last even longer.

What is NAMSA’s biocompatibility strategy navigator?

NAMSA’s Biocompatibility Strategy Navigator was developed to help simplify the maze of biological tests required for client-specific regulatory pathways. No matter your testing goals, NAMSA can deliver a personalized, reliable and cost-effective testing solution for your development efforts.

What is the purpose of the NAMSA test?

NAMSA performs testing to evaluate biocompatibility appropriate to the intended use of the component material or finished product. These biocompatibility tests challenge various biological models with the test material or a suitable extract. Specific safety programs follow FDA guidance and ISO 10993 standards.

Why choose NAMSA for biological safety training?

NAMSA provides industry-leading biological safety training to the medical device industry. With over 2,000 attendees to date, our customized approach to applying ISO 10993 principles and other regulatory guidance in every day scenarios is unrivaled within the medical device marketplace.

What is a biocompatibility test?

NAMSA’s biocompatibility tests challenge various biological models with test materials or suitable extracts. Specific safety programs follow FDA guidance, ISO 10993 standards and other international guidelines. Primary test categories used to determine biological effect include: