Medical Device Biological Safety Consulting

Biological Safety Consulting

Planning for biological safety is as much a business necessity as it is a regulatory requirement. Any novel device must undergo assessment for biological hazards, risk characterization, and toxicological risk assessment while also meeting the test requirements of varying international marketplaces and geographies. While the requirements for the FDA EU and other international regulators are well documented, the actual path to approval is sometimes not clear and many situations require a more strategic approach. Spending time mapping out the requirements for your specific product can save a lot of money and time down the road.

We frequently start by helping clients develop a robust gap analysis to establish a baseline of where you are. With a solid understanding of potential shortcomings, we can develop an overall testing strategy.

Biological Safety Strategy and Consulting Services

NAMSA conducted 118,000+ medical device tests last year so we have seen nearly every variation of device across a wide variety of therapeutic areas. Our team includes former Notified Body reviewers, toxicologists, preclinical scientists, clinical specialists, and regulatory consultants. Because we specialize in medical devices and offer integrated services that cross the entire development spectrum, we offer a holistic view of what will be required to make your product compliant with FDA, EU, and other regulations. We offer a range of biological safety consulting solutions to ensure your medical device development program is compliant, while also focusing on the most efficient means possible to complete necessary tests.

Overall testing strategy
Biological Evaluation Plans (BEP)
Biological Evaluation Reports (BER)
Toxicological and Equivalency Assessments
Gap analyses and peer reviews
Biological safety training

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Medical Device Toxicology Risk Assessment

Toxicological Risk Assessment
This assessment evaluates the toxicity of individual chemical ingredients of the formulation used to manufacture a particular medical device. The assessment typically includes tests for chemical composition, extractables and/or leachables, and evaluation of any degradable or leachable materials to determine patient biological risk. This assessment is often a component of a Biological Evaluation Report where analytical chemistry testing is performed.

Equivalency Assessment
NAMSA’s Equivalency Assessment evaluates the equivalency of a device to another similar marketed product. A typical request includes equivalency regarding data and properties for clinical, technical, and biological parameters, methods of use, materials, and equivalent clinical, technical, and biological properties performance.