Post-Market

Once your product has been approved and is out on the market, the post-market stage is never ending. This stage is focused on the continued monitoring of your product safety. Some of the operations that take place during the post-market stage are as follows:

  • Physician training & continued promotion efforts
  • Lot release testing
  • Process improvements as needed
  • Update design control documents as needed
  • Quality audits
  • Ongoing Materials Characterization

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 Auditing Services

NAMSA provides expert clinical auditing services to medical device manufacturers and corporate and financial investors. With more than 18 years of experience in the clinical trial consulting business, we have …

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 …

CTMS Services/Medical Data Management

Depending on your needs, NAMSA offers both paper-based and electronic data capture (EDC) platforms for comprehensive data management support. In 2011, we partnered with the MedNet Solutions  and began offering the medical …

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 …

Biostatistics Consulting & Services

NAMSA employs a highly experienced cadre of medical device-focused biostatisticians. Having come from Boston Scientific, Medtronic, United Health, Mayo Clinic, and 3M, our team members average over 15 years of experience …

Other Microbiology Testing Services

NAMSA’s Testing Capabilities include all areas of microbiological quality assurance. Our well-equipped facilities contain laboratories for bacteriology and sterility testing, clean rooms, aging chambers and media preparation areas. Beyond sterility …

Validation for Reprocessed Medical Devices

Reusable medical devices have been used in health-care facilities for more than a century. Today’s designs are complex and sophisticated, and the process of cleaning, disinfecting, and sterilizing reusable devices …

Packaging Validation Services

Packaging Validation and Shelf Life Testing are essential components of your sterility assurance program. These tests ensure that sterility is maintained when a device is sealed in a package until expiration. We …

Environmental Monitoring Services

Environmental monitoring is performed to meet the requirements of quality system regulation when such an environment can influence the pre-sterilization bioburden level or resistance on a medical device. Our medical …

Sterilization Validation Services

Medical device Sterilization Validation Studies are performed for all processes, including radiation sterilization by either gamma radiation or electron beam, ethylene oxide gas sterilization, hydrogen peroxide sterilization and thermal sterilization (both …

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 …

Human Anatomic Services

When it’s time for Anatomic Services, NAMSA offers the most trusted services in the industry NAMSA’s research facility in Brooklyn Park, Minnesota offers a state of the art surgical facilities …

Method Development and Validation Services

NAMSA offers technical consulting along with research method development capabilities. This unique combination of clinical advisory and validation services, coupled with fully equipped R&D laboratories, allow us to provide insight into …

Cleaning Study Development & Execution

Traditionally, when the topic of medical device cleaning studies is approached, the focus is on sterility and biocompatibility aspects, including particulate analysis, bioburden, LAL, and cytotoxicity testing. The component that …

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 …

Histopathology Services

The NAMSA Advantage NAMSA’s provides advanced histological technology for the testing and evaluation of implanted medical devices. Valuable tissues can be collected and processed on-site under the supervision of a …

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 …

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 …

Medical Device Validation & Safety Consulting

In the world of medical device design, expertise in biocompatibility, sterilization, and validation for regulatory submissions is a prized commodity. NAMSA’s Product Safety and Validation Services Group is home to …

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 …