Design Validation / Preclinical Testing

This is the stage of the development process in which the design of the product is set, such as functionality and safety aspects, and validation of the selected materials and processes begins. Additional operations that occur during this stage include, but are not limited to:

  • Regulatory strategy, reimbursement strategy and competitive assessment update
  • Pre-IDE documents and meeting
  • Beginning Quality System development (Manual and SOPs)
  • Designing Risk Analysis (FMEA/FTA) & Hazard Analysis (HA) & Process FMEA
  • Developing clinical plan and preliminary protocol

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 …

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 …

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 …

Biocompatibility Testing Services

Safety evaluation studies (in vitro and in vivo) are conducted on a variety of biomaterials, medical devices, and related products to identify the presence of toxins or any other potentially …

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 …

Particulate Analysis Services

The purpose of the medical device particulates testing is to determine the quantity and size of particles on the device or in the solution. With the addition of TIR 42, …

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 …

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 risk assessment for biological hazards …

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 …

Preclinical Studies

We help medical device manufacturers test and verify product performance according to intended function. Efficacy studies—part of NAMSA’s Preclinical studies—are used to select prototypes and provide an understanding of device …

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 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 …