In the world of medical device design, expertise in biocompatibility, sterilization, and validation for regulatory submissions is a prized commodity. NAMSA’s Product Safety and Validation Services Group is home to thought-leading experts who provide strategic advice and support that saves time and money — all with an eye on regulatory compliance.
Areas of Expertise
- Materials science
- Environmental monitoring and controls in production
- General analytical chemistry
- General microbiology
- Process validation
- Disinfection efficacy validation
- Cleaning efficacy validation
The cleaning instructions manufacturers provide for products that can be reprocessed need to be closely considered and refined to better ensure compliance with the latest FDA guidance and offer cleaning methods that are convenient, detailed and efficient for end users. The FDA has increased oversight and expectations in the area of validated cleaning processes to support the manufacturer’s defined cleaning instructions. As a result, it has become more critical to be prepared with appropriate instructions for use and thorough efficacy validations. NAMSA has a great deal of experience in assisting with the development and refinement of cleaning instructions that comply with the most recent developments and guidance from the FDA as well as with the preparation of protocols and final reports and review of the laboratory data associated with these studies. We feel that our knowledge combined with the ability to troubleshoot and provide quality consultation on these issues greatly benefits Medical Device Manufacturers.
Common Assignments include development and administration of a plan for a Cleaning Effectiveness Study by:
- Gathering information on the product(s)
- Researching cleaning procedures provided by the manufacturers of like use devices
- Providing guidance on and cooperatively developing and refining the cleaning procedures proposed for the instructions for use
- Preparing detailed validation protocols to meet regulatory guidance
- Guiding, consulting and troubleshooting testing performed by a qualified laboratory
- Reviewing laboratory data to ensure compliance with protocol requirements
- Compiling laboratory results and prepare Final Reports
- Risk Assessment: NAMSA evaluates the biological risk associated with a product or material, as required by ISO 10993-1 (2009) and the EU Medical Device Directives. We look at predicates, materials, processes, and composites to inform you of biological and toxicological hazards and regulatory implications, known and potential. We also recommend ways to mitigate risk, whether through testing or by establishing the safety of the materials and processes.
- Test Planning: Smart companies know what tests they need before they begin device development. NAMSA can perform an assessment of your products and needs, and present a testing road map that facilitates planning, and budgeting.
- Reality Check: Gathering competitive quotes for testing services is one thing, but knowing whether you need them is another. We can evaluate the necessity and appropriateness of your test plans and offer options or recommendations. We’re invested in helping you stick to what’s necessary, cost-effective, and timely.
- Ad Hoc Consulting: Need a question answered? Have an issue to be researched? Looking for advice on how to reply to the FDA about a biological safety issue or a reprocessing validation issue? We will furnish expert consultants on an hourly basis or on retainer.
- Crisis Support: Either before or after you receive notification of an FDA inspection, or are issued a 483, or a warning letter, NAMSA can assist you with preparation or development of an effective response.
The Value Our Product Safety and Validation Services:
- Time and Money: NAMSA’s insights and strategic thinking can eliminate months and many thousands of dollars from your development cycle. Laboratories sell tests. We evaluate the need for testing.
- Regulatory Compliance: We provide our clients with peace of mind that our recommendations will meet the requirements of consensus standards, FDA guidances, and international regulatory bodies.
- Clarity: We provide clarity and context to complex materials safety issues.
Scale: Our support and recommendations to every client are customized. We do only the work you need and no more.