Market Approval

The market approval stage is pretty self-explanatory. This is the time of the development process when your device is submitted for approval by the appropriate governing regulatory body. A few of the steps that can be expected to occur during this stage include:

  • Develop customer training plan
  • Final patent review with R&D
  • Market approval application
  • Finalize risk management report
  • Prepare for pre-approval inspections
  • Optimization of manufacturing process
  • Quality system complete

Clinical Research Management

In medical device product development, the clinical study phase is the most time consuming, least predictable, most expensive, and most important. NAMSA uses optimal strategies and tools to guide you …

Clinical Evidence / Post-Market Studies

Medical device manufacturers know that regulatory approval can be meaningless without clinical evidence to back their product claims and reimbursement. We offer a broad array of support levels to help …

Medical Writing Services

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 …

Data Safety Reporting/Clinical Events

NAMSA provides expert support for clinical events committees (CECs) and data monitoring committees and data safety / monitoring committees (DMCs/DSMBs). For many medical device manufacturers, managing the administrative details and …

Field Clinical Engineer Staffing

Seasoned industry Field Clinical Engineering (FCE) staff can make the difference in whether your medical device trial produces high quality data and meets/exceeds enrollment expectations, translating into an overall reduction …

Clinical Study Design

You want clinical study design and protocols that balance the interests of multiple stakeholders without breaking the bank. NAMSA brings together experts—clinical, regulatory, statistical, marketing and health economics—and puts them …

Physician Training

With unequalled experience and expertise, NAMSA offers the most complete physician training experience in the industry. The interaction between medical device manufacturers and health care professionals is extremely valuable to …

Long-Term or Accelerated Shelf Life Testing

ICH Stability Studies Due to the integration of active pharmaceutical ingredients (API) and antimicrobial agents, more medical devices are being considered combination products than ever before. While the stability of …

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 …

FDA U.S. Agent Services

NAMSA Can Act as Your United States Agent As part of FDA’s Medical Device Registration and Listing requirements, establishments outside the United States must designate a U.S. Agent. Click the …

International Medical Device Registration Consulting

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 …

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 Clinical Research Staffing

NAMSA offers on-site support at every stage of product development to assist your team and partner in your company’s success anywhere in the world. Common On-Site Support Assignments Deadline or …

ISO Compliance & Quality Systems Consulting

NAMSA offers comprehensive support to medical device companies in the areas of FDA quality system regulation (QSR) and ISO compliance for medical device companies. Design Controls We develop and implement …

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 …