A wide range of medical devices are introduced almost daily in today’s market, and established standards are constantly being redefined. Any novel device needs to undergo assessment for biological hazards, risk characterization and toxicological risk assessment. On top of that, any product development process must meet the testing requirements of various international markets. Planning for biocompatibility, then, is as much a business necessity as it is a regulatory requirement.
At NAMSA, we offer a range of Biological Safety Services to protect your medical device development process and keep it moving forward. Our services include:
Biological Risk Assessment
As part of thorough a Biological Risk Assessment, NAMSA’s expert toxicologists will document the biological risk, associated biological endpoints and outline a strategy (research / testing plan) to assess the biological safety of a medical device.
Once the recommended testing is completed and assessed (Toxilogical / Chemistry Assessment), all relative research and results will be harmonized into a final summary document to determine if all areas of biological risk, or the relationship between the hazard and potential exposure (endpoints) have been addressed and tailored to your regulatory body requirements. This process will most often include risk characterization / identification, testing strategy, predicate device review, biocompatibility testing rationale and results, chemical characterization interpretation, clinical data review, as well as prior use and technical literature research information.
Biological Safety Evaluation Plan
NAMSA’s Biological Safety Evaluation Plan summarizes and characterizes a medical device based on the nature and duration of body contact, assesses the selection and materials of construction, reviews the manufacturing processes, identifies the minimum biological endpoints of concern, evaluates any existing research data available and recommends and supports a testing strategy (plan) to address areas of remaining biological risk.
Toxicological / Chemical Risk Assessment
This Assessment assesses the toxicity of the individual chemical ingredients of the formulation used to manufacture a medical device. The assessment typically includes test for chemical composition, identifying extractable and or leachable, and evaluation of any degradable or leachable materials to identify biological risk to patients or users.
NAMSA can review your medical device for equivalency to another marketed device. A typical request includes equivalency regarding data and properties for clinical, technical and biological parameters, method of use, materials as well as equivalent clinical, technical and biological properties performance.
FDA and Notified Body Response Support
NAMSA can provide the industry expertise to ensure expedient and effective responses to all regulatory body requests. Our teams interact with global regulatory bodies on a daily basis and understand the importance of the correct information and how to present it for regulatory success.
NAMSA’s team of Board Certified Toxicologists (DABTs) are available to provide credibility as a third party reviewer to vigorously critique your scientific claims and research to ensure integrity of your data, resultant claims and the best possible science.
Adverse Test Result Technical Memo
NAMSA’s technical experts can assist in providing technical clarity of adverse results, their implications and relevance to the known biological / toxilogocal endpoints relative to your specific medical device and regulatory pathway(s).
Ad Hoc Consulting
At NAMSA, we understand the challenges involved throughout the medical device development process, as well as the concerns regarding the latest changes in standards to be considered when trying to achieve regulatory success. Our team of experts are available on an Ad Hoc basis to consult and provide relevant feedback and recommendations regarding all phases and actions required for efficient and successful medical device development.
NAMSA offers a comprehensive analysis detailing the acceptable and deficient areas (Gap) between an existing set of data and new regulatory requirements for devices, including a report of recommendations on remediation and sequence.
NAMSA provides industry-leading biological safety training to the medical device industry, with 2,000+ global attendees annually. Our customized approach to explaining the application of ISO 10993 principles and other regulatory guidance is unrivaled within the medical device marketplace. NAMSA provides three specialty courses focused on the biological evaluation of medical devices including:
- Biological safety specialist certification
- Advanced workshop on the biological evaluation process
- Custom workshop focused on chemical characterization
For additional resources, please access the links below:
- Biocompatibility Strategy Navigator: Developed to help navigate and simplify the maze of biological testing required based on the regulatory pathway of your unique medical device.
- White Paper: Reducing Medical Device Development Timelines and Creating Value through Biological Risk Assessments and Chemical Characterization
- Webinar: The New ISO 10993:1 2018 – What Now?
- NAMSA Training Series