As you work on creating a new medical device or related technology, it is vital that you understand and define the best materials science strategy for your device. NAMSA Advisory Services help you lay a solid foundation with careful and thorough first steps.

We guide you toward a successful device with:

• Material Compatibility Studies – troubleshoot compatibility problems, particularly issues with radiation sterilization.
• Material Selection – assist with the process to select the most compatible material.
• Method Development – help create consistent, reliable and efficient processes.

The design phase of any development cycle can be considered the most critical. It is where fundamental decisions are made that will impact issues like safety and manufacturing cost. With our consulting expertise in product safety and cost reductions, NAMSA Advisory Services can help you stay on track.

Our assistance during this phase can include:

• Biocompatibility Studies - resolve regulatory problems and identify issues critical to FDA submission and approval.
• ISO 10997-7 - establish EO dissipation curves and troubleshoot critical issues.
• Risk Analysis - reduce testing and provide supporting documentation.
• Cost Reductions - conduct a thorough review of your programs identifying areas where cost savings can be initiated.

During the manufacturing phase we offer several categories of services, all aimed at improving manufacturing processes, reducing potential contaminants and increasing speed to market.

Specifically, NAMSA Advisory Services offer:

• Packaging Qualification - quality material selections, process control and final packaging solutions.
• Shelf-life Qualification - plan, perform and document shelf-life studies.
• Cleaning Studies - prove that cleaning methods are safe and effective. We can also provide Clean Room Validation.
• Water System Validation - assure that your DI or WFI system produces water and meets specifications consistently.
• Environmental Monitoring - develop procedures, complete testing and set limits.
• Bioburden Data Analysis - conduct data analysis and trending calculations.
• SOP Preparation - develop most effective standard operating procedures.

After your product is made, NAMSA will help you with services all aimed at validating sterilization processes and results as well as quality control issues. So you can be sure that through manufacturing, shipping and application, your device is the best it can be.

Ensure the quality of your product with services including:

• EO Sterilization Cycle Development and Sterilization Validation - plan and perform studies to optimize EO cycles that can consistently provide lethality.
• Parametric Release - plan and perform studies to enable release of product without biological indicators.
• Product Adoption - reduce costs by consolidating cycles under product families.
• Biological Indicators Reduced Incubation Time (RIT) - increase revenue and decrease inventory cost by releasing products to market sooner.
• Gamma Irradiation Sterilization Validation - dose setting studies and recommendations.
• Beam Sterilization Validation - dose setting studies and recommendations.
• 21CFR820 Assistance - GMP compliance troubleshooting and auditing services.
• 510k Submissions - preparation and submission assistance.
• Validation Master Plans - preparing planning documents for validation.