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

The services of a world-class contract research organization (CRO), such as NAMSA, can be invaluable during this stage.

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’s clinical research management services utilize optimal strategies and …

Clinical Auditing Services

NAMSA provides expert clinical auditing services to medical device manufacturers and corporate and financial investors. With nearly 20 years of experience in the clinical research services and trial consulting business, …

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 contract research organization (CRO) …

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 …

Data Safety Reporting & Clinical Events

NAMSA, a world-class clinical research organization (CRO), provides expert support for clinical events committees (CECs) and data monitoring committees and data safety / monitoring committees (DMCs/DSMBs). For many medical device …

CTMS Services & Medical Data Management

Depending on your needs, NAMSA offers both paper-based and electronic data capture (EDC) and clinical trial management system (CTMS) platforms for comprehensive data management support. In 2011, we partnered with …

Field Clinical Engineer Staffing

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

Clinical Study Design

You want clinical study design and protocols that balance the interests of multiple stakeholders without breaking the bank. NAMSA, a leading contract research organization (CRO), brings together experts—clinical, regulatory, statistical, …

Biostatistics Consulting & Services

NAMSA employs a highly experienced team 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 world-class clinical research organization (CRO) 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 …

Validation for Reprocessed Medical Devices

Reusable medical devices have been used in healthcare 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. NAMSA, …

Environmental Monitoring Services

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

Physician Training

With unequaled experience and expertise, NAMSA is a leading contract research organization (CRO) that offers the most complete physician training experience in the industry. The interaction between medical device manufacturers …

Human Anatomic Services

When it’s time for Anatomic Services, NAMSA offers the most trusted clinical research organization (CRO) services in the industry NAMSA’s research facility in Brooklyn Park, Minnesota offers a state of …

Method Development & 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 testing issues and …

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 is often …

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 these ingredients …

Histopathology Services

The NAMSA Advantage NAMSA’s provides advanced contract research organization (CRO) histological technology for the testing and evaluation of implanted medical devices. Valuable tissues can be collected and processed on-site under …

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 …

FDA U.S. Agent Services

NAMSA Can Act as Your United States Agent As part of FDA’s Medical Device Registration and Listing requirements pertaining to medical device approval, organizations outside the United States must designate …

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 Clinical Research Staffing

NAMSA offers on-site consulting 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 …

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 leading …

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 …