NAMSA is a contract research organization (CRO) that provides outsourced research and development services to medical device companies.
Every year more than 3,000 medical devices and In Vitro Diagnostic companies worldwide trust NAMSA to help them bring innovative new products to market or ensure the ongoing safety of their existing products. Our team of 1,400 specialists are ready to help you conduct market research, preclinical studies, clinical trials, biological safety testing, regulatory submissions, and much more.
Below is a short summary of our services:
Medical device testing:
- Biocompatibility testing according to ISO 10993-1
- Pre-clinical testing according to ISO 10993-6
- Histopathology
- Cleaning validation, sterilization validation and disinfection validation
- Packaging validation,
- Shelf-life testing
- Sterility Testing
- Chemical characterization according to ISO 10993-18
ISO 17025 accredited and GLP compliant testing.
Biological safety consulting:
- Biological evaluation plans and reports (BEPs and BERs)
- Toxicological Risk Assessment (TRA)
- Ad hoc support (e.g. gap analysis, peer review, test results memos)
- NAMSA Training series focusing on biological safety (biocompatibility and chemical characterization / toxicological risk assessment) offered twice per year
Regulatory and quality consulting:
- Regulatory Strategy
- MDR and IVDR Consulting
- Quality Management Systems and Audits
- US FDA: Pre-submission, PMA, 510(k), De Novo and IDE submissions
Reimbursement services:
- Reimbursement strategy
- Code Analysis and Applications
- Health Economics Analysis
Medical writing services:
- Clinical Evaluation Plan and Clinical Evaluation Report
- Performance Evaluation Plan and Performance Evaluation Report
- Clinical Literature Reviews
- Periodic Safety Update Reports (PSUR)
- Post Market Surveillance Reports (PMSR)
- Summaries of Safety and Clinical Performance (SSCP)
- Clinical Study Protocols
- Clinical Study Reports (CSR)
Clinical research:
- Clinical Study Management
- Clinical Site Management
- Clinical Safety and Reporting
- Biostatistics and Statistical programming,
- Data Management and EDC
- Medical Imaging Core Lab
- Human Factors
Market Research
- Market Opportunity
- Value Proposition
- Pricing
- Claim Evidence Generation
