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. NAMSA provides contract research organization (CRO) services to assist medical device manufacturers with the following processes:

  • 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

Medical Writing Services

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

Medical Device 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 Risk Assessment Services

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 assessment for biological hazards, risk …

Material Characterization & Analytical Chemistry

NAMSA’s chemistry laboratory services 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 and …

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 Medical Device Registration Consulting

NAMSA is a leading Clinical Research Organization (CRO), and the world’s only Medical Research Organization (MRO), that assists medical device manufacturers seeking to conduct clinical trials or commercialize products in various international …

Medical Device Strategy 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 medical device …

Medical Device 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 …