Site Map
- Accreditations & Certifications
- APEX PROGRAM
- Careers
- History
- Labcorp Has Transitioned Their Early Development Medical Device Testing Business to NAMSA
- Partnerships
- NAMSA Program for Abbott
- NAMSA Program for Terumo Companies
- NAMSA Program for ICU Medical
- MRI Imaging for Preclinical Studies
- NAMSA Program for Terumo Companies
- WuXi AppTec US Medical Device Testing Is Now NAMSA
- Frequently Asked Questions from WuXi AppTec US Medical Device Testing Clients
- Client Portals
- Newsletter Sign Up
- NAMSA Acquires AKRN
- NAMSA Acquires American Preclinical Services
- NAMSA Acquires CRI
- NAMSA Acquires Medanex
- NAMSA Acquires Perfectus
- NAMSA Acquires SUAZIO
- NAMSA Acquires Syntactx
- NAMSA Leadership Team
- Therapeutic Devices
- Cardiovascular Devices
- Dental Devices
- Diabetes Care Devices
- Gastroenterology Devices
- IVD Devices
- Neurovascular Devices
- Ophthalmology Devices
- Cardiovascular Device Expertise
- Peripheral Vascular Devices
- General Surgery Devices
- Wound Care Devices
- HCT/P Cell & Tissue Products
- EXPE-C001 – Team
- Clinical Services
- Clinical Study Design
- Clinical Trial Management
- Clinical Data Management
- Biostatistics Consulting
- Pivotal Clinical Trials
- Post-Market Clinical Studies
- PMCF Surveys
- Premarket Clinical Evidence
- Clinical Study Reporting (CSR)
- Imaging Core Lab
- Clinical Data Safety and Monitoring
- Medical Writing
- FSP Outsourcing
- Post-Market Clinical Evidence
- Clinical Trial Rescue Studies
- Clinical Trial Execution
- Consulting Services
- EU MDR & IVDR Consulting
- Post Market Surveillance (PMS)
- Clinical Evaluation Reports
- Clinical Evaluation Reports
- Summary of Safety and Performance (SSP)
- Summary of Safety and Clinical Performance (SSCP)
- EU Technical Documentation
- PMCF Plans, Surveys and Reports
- IVDR PMPF Plans, Studies, and Reports
- Periodic Safety Update Report (PSUR)
- US FDA Consulting
- FDA 510(k) Consultants
- FDA De Novo Submissions
- Investigational Device Exemptions (FDA IDE) for Medical Devices
- FDA PMA Consulting
- FDA Pre-Submission and Q-Sub Submission Consulting for Medical Devices
- US FDA Breakthrough Designation
- Global Consulting
- Global RA/QA Consulting
- Borderline and Combination Products
- Literature Reviews
- QMS Implementation
- QMS Audits
- MDSAP Compliance
- ISO 14971 Risk Management
- Medical Device Clinical and Regulatory Strategy Roadmap Consulting
- Animal Tissue Device Support
- AI and Medical Device Software Regulatory Support
- Human Factors
- Biological Safety Consulting
- Preclinical Research
- Medical Device Testing
- Biocompatibility Strategy Navigator
- Test Navigator
- Biocompatibility Testing
- Genotoxicity Testing
- Hemocompatibility Testing
- Cytotoxicity Testing
- Histopathology Services
- Sensitization Testing
- Systemic Toxicity Testing
- ISO 10993-18: Extractables and Leachables Testing
- Microbiology Testing
- Sterility Testing and Validation
