NAMSA provides the flexible, responsive guidance you need for every stage of the product development process.
That's why we offer you a broad range of services, including:
- on-site consulting and investigation.
- global regulatory planning and meeting preparation.
- audits, assessments and benchmarking.
- focused recommendations and reports.
- on-site seminars and training.
It's also why we offer services from the beginning to the end of the product development process—so you get the guidance you need when and where you need it most.
We can serve as a guide through any or all of the steps it takes to get a medical device to market.
Regulatory Strategy
- risk reduction
- cost reduction
- time reduction
Research and Development
- material analysis
- material selection
- method development
- literature search
Design
- product safety
- product efficacy
- risk assessment
- certificates of compliance
- regulatory submissions
Manufacturing
- packaging validation
- sterilization validation
- process validation
- contamination control
- cleanroom validation
Quality Assurance
- regulatory compliance
- quality audits
- FDA assistance
- failure investigation
