Concept / Feasibility

While the concept and feasibility stage in product design and development processes are not required by regulations or harmonized standards, the processes undergone in this stage helps minimize risk during product development and can prevent unexpected failures during design verification and validation testing. Some of these processes include:

  • Defining customer requirements, market analysis and competitive assessment
  • Developing concepts/plans/schedules/models
  • Early risk assessment
  • Non-GLP Functional/Efficacy studies
  • Initial regulatory, clinical and reimbursement assessment & strategy

Technical Writing

NAMSA provides professional report writing and manuscript submission services to medical device manufacturers. We employ postgraduate-level clinical and scientific experts who have contributed in part or in whole to clinical …

Product & Process Risk Assessment

NAMSA evaluates the biological risk associated with a medical device product or material, as required by ISO 10993-1 (2009) and the EU Medical Device Directives. We look at predicates, materials, …

Biological Safety Evaluation Plans

A wide range of medical devices are introduced almost daily in today’s market, and established standards are constantly being redefined. Any novel device needs to undergo risk assessment for biological hazards …

Material Characterization & Analytical Chemistry

NAMSA’s chemistry laboratories provide analytical support for the development and quality audit of medical devices, reagents, and excipients. Most of our work in this area is instrumental analysis of polymers …

Mock Audits

As efficiency and success typically grow from preparation, mock audits are conducted by experienced and trusted consultants to significantly assist manufacturers, suppliers or sub-contractors in the new era of Medical …

International Registrations

NAMSA assists medical device manufacturers seeking to conduct clinical trials or commercialize products in various international markets. Most Common Market Registrations and Filings Requested EU member nations Canada Australia Switzerland …

Strategic Consulting

You’re moving from concept to launch. We know the best way to get there. NAMSA is your trusted partner in medical device product development and clinical compliance support. We offer …

Regulatory Consulting

In today’s market, medical device companies pursuing commercialization need a global regulatory strategy. We offer strategic guidance at every stage of the product development process. Our regulatory experts have specialized …