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Your Guide to Biostatistics Outsourcing and Consulting

On March 30, 2023, the U.S. FDA issued draft guidance outlining the use of Predetermined Change Control Plans (PCCPs) for AI/ML software.

NAMSA Expands MedTech Portfolio in Market Intelligence and Customer Research Services through its Acquisition of EU-Based SUAZIO

NAMSA announced today its acquisition of SUAZIO, an EU-based strategic consultancy providing global market research services to medical device and IVD developers.    

NAMSA Transforms Integrated MedTech Commercialization Solution: The NAMSA APEX Program

NAMSA announced today the transformation of its integrated MedTech commercialization solution: the NAMSA APEX Program. NAMSA’s strategic outsourcing solution is introduced at a time when the MedTech industry is experiencing changing regulatory requirements and expanding clinical evidence demands

NAMSA ACQUIRES UK-BASED PERFECTUS BIOMED GROUP TO ENHANCE CUSTOMIZED MICROBIOLOGICAL SOLUTIONS

NAMSA, a world-leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today its acquisition of Perfectus Biomed Group, a UK-based laboratory providing customized microbiological services.

NAMSA and InspireMD Announce Strategic Outsourcing Partnership to Accelerate New Product Development

NAMSA and InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention System (EPS) for treatment of carotid artery disease and prevention of stroke, announced today that they have entered into a strategic outsourcing partnership to accelerate medical device development and commercialization.

NAMSA ACQUIRES EUROPEAN-BASED MEDANEX CLINIC TO EXPAND EARLY-STAGE PRECLINICAL RESEARCH CAPABILITIES

NAMSA announced today its nearing acquisition of Medanex Clinic, a Belgium-based European preclinical research organization. Medanex’s robust preclinical capabilities and expertise, specifically in the Cardiovascular arena, will help enhance NAMSA capabilities and over Client experience.

NAMSA ACQUIRES CONTRACT RESEARCH ORGANIZATION, ÅKRN

NAMSA announced its intent to acquire ÅKRN Scientific Consulting, a prominent European Medical Device CRO based in Madrid, Spain. The acquisition of ÅKRN increases NAMSA’s global scale, now serving MedTech Clients across 19 locations throughout APAC, Europe, North America and South America.

NAMSA Expands Minneapolis Preclinical Laboratory to Meet Industry Demand for Medtech Research and Development Solutions

NAMSA, the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today the expansion of its Minneapolis preclinical research laboratory. This expansion will add 55,000 sq. ft. to the current 130,000 sq. ft. preclinical campus in Minneapolis.

NAMSA ACQUIRES LEADING CLINICAL RESEARCH ORGANIZATION CLINLOGIX TO ENHANCE THERAPEUTIC EXPERTISE AND GLOBAL FOOTPRINT

NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Clinlogix, a leading, Philadelphia-based global clinical research organization. Third in an advancing series, this acquisition follows NAMSA’s purchase announcements of Syntactx and American Preclinical Services (APS) in early 2021.

NAMSA First to Receive FDA ASCA Accreditation for Medical Device Biocompatibility Testing

Medical device and diagnostic manufacturers seeking acceleration of U.S. Food and Drug Administration (FDA) approval may benefit from one of two purpose-built FDA programs: 1) the Breakthrough Devices Program; and 2) the Safer Technologies Program (STeP). The benefits of these programs are substantial for manufacturers who apply, qualify and are granted designation by FDA.

Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership

NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in new hands.

NAMSA Begins Next Chapter of Growth under Newly Appointed CEO, Dr. Christophe Berthoux

NAMSA®, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its executive leadership transition plan with the appointment of Dr. Christophe Berthoux as NAMSA’s new CEO, effective March 22, 2021.

NAMSA Acquires American Preclinical Services

NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Minneapolis-based American Preclinical Services (APS), a full service preclinical CRO. This purchase follows NAMSA’s acquisition of New York-based Syntactx, a leading clinical research services CRO, in January 2021. 

NAMSA® Acquires Syntactx to Enhance End-to-End CRO Development Solutions, Expanding Medical Device Clinical Research Capabilities and Expertise

NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of New York-based CRO, Syntactx. This acquisition follows independent healthcare investment firm ArchiMed’s majority interest purchase of NAMSA in September 2020.

Archimed Acquires Majority Interest in NAMSA

Private equity healthcare specialist ArchiMed has acquired from the founding Gorski Family a majority stake in NAMSA, the only full continuum Contract Research Organization (CRO) in the world focused exclusively on medical devices. NAMSA’s President and CEO, John Gorski, the Gorski Family and senior managers will hold stake in the company amounting to a significant double-digit percentage. The price of the transaction is undisclosed.

PharmTech Outlook: Cover Story Featuring NAMSA President & CEO, John Gorski

Over the last decade, the pharmaceutical and medical device industries have undergone significant transformative trends and innovations. These shifts have rapidly improved efficiency and lowered costs while bringing an increased focus to personalized patient care. According to a 2019 study by Research and Markets, sales in the pharmaceutical industry are expected to rise to $900 billion in 2019 to $1.2 trillion by 2024, while the global medical device market is expected to grow at a CAGR of 5.33 percent to $521.64 billion by 2022.

NAMSA Expands European Medical Device Testing Solutions with DAkkS DIN ISO/IEC 17025:2018 Accreditation in Germany

Tuesday, October 8, 2019–FRANKFURT, Germany–(BUSINESS WIRE)–NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated testing, clinical research, and reimbursement and regulatory consulting services, is pleased to announce that it has been awarded DIN EN ISO/IEC 17025:2018 accreditation by DAkkS. DAkkS, the sole national accreditation body for the Federal Republic … Continued

Chinese State Drug Administration Releases ‘Notice on the Implementation of Electronic Declaration of Medical Device Registration’

In order to implement relevant requirements in the “Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Drug Medical Devices,” the Chinese State Drug Administration issued the “Notice on the Implementation of Electronic Declaration of Medical Device Registration” (No. 46 of 2019) on May 31, 2019. Simultaneously, the … Continued

NAMSA Recognized as Leading Medical Device CRO for Third Consecutive Year by Life Science Leader

TOLEDO, Ohio – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research, and regulatory and reimbursement consulting services, announced today that it has been recognized for excellence in clinical research and honored for the third consecutive year as a 2019 “CRO Leadership Award” winner. The … Continued

NAMSA Announces Acquisition of Reimbursement Strategies, LLC, Expands Medical Device Development Portfolio

TOLEDO, OHIO (BUSINESSWIRE)—January 7, 2019—NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services, is pleased to announce the acquisition of Reimbursement Strategies, LLC, a Minneapolis-based consultancy focused on reimbursement, health economics and market access for the international life science industry. For … Continued

NAMSA® Launches Chinese Website to Provide Medical Device Development Resource to APAC Sponsors

SHANGHAI, CHINA – (BUSINESS WIRE) – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical research and regulatory consulting services, is excited to announce the launch of its newly-developed website to serve as a new resource for Asia-Pacific (APAC) medical device sponsors. The introduction of this highly-anticipated website is … Continued

NAMSA® Launches Market Intelligence Report on Global Medical Device Clinical Outsourcing Trends

TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services is pleased to announce the release of its 2018 Medical Device Landscape Report: Trends and Challenges in Clinical Research Outsourcing. This report, conducted on behalf of … Continued

NAMSA Launches Online Biocompatibility Strategy Application to Streamline Development Efforts for Global Medical Device Manufacturers

August 28, 2018 – TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services is pleased to announce the launch of its new online development application,  the NAMSA Biocompatibility Strategy Navigator. This first-of-a-kind web-based resource assists device manufacturers to … Continued

NAMSA® Launches “Uniquely IVD” Development Services to Expedite in vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers

TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services, announced today the launch of its in vitro diagnostic (IVD) development business to provide global manufacturers a proven resource for expedited commercialization outcomes delivered via NAMSA’s “Uniquely IVD” … Continued

NAMSA Recognized as Leading Medical Device CRO for Second Consecutive Year by Life Science Leader

TOLEDO, Ohio – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical research and regulatory consulting services, announced today that it has been recognized for excellence in clinical research and honored for the second consecutive year as a 2018 “CRO Leadership Award” winner. The CRO … Continued

Japan’s PMDA to Raise Medical Device and IVD Registration User Fees Beginning April 2018

On 31 January 2018, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) released Cabinet Order No. 24 which sets forth changes for medical device and IVD registration user fees. These changes, which include increases from 8 to 15 percent, are effective 01 April 2018. To assist medical device manufacturers in assessing the impact of these changes … Continued

NAMSA Introduces French Website to Provide Resource for Accelerated Medical Device Development in Europe

28 FEBRUARY 2018 – LYON, FRANCE – (BUSINESS WIRE) – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical research and regulatory consulting services, is pleased to introduce its newly launched French language website. The release of this online resource comes as a result of significant, increased demand … Continued

NAMSA Expands Medical Device Testing Services in Germany to Increase Access to Accelerated Product Development

The world’s only Medical Research Organization brings 50 years of testing leadership to Germany with new Analytical Services Laboratory. FRANKFURT, GERMANY – February 1, 2018 – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated testing, clinical research and regulatory consulting services, is pleased to announce the launch of … Continued

Japan’s “Ninsho Kijun” Regulatory Approval Pathway

Medical device products throughout the globe are characteristically classified by their specific risk level or category. This is no different in Japan, the world’s third largest medical device marketplace; however, there are important and very different considerations for manufacturers of Class II and III products in this territory than in any other part of the … Continued

NAMSA Launches German Website to Support Europe’s Largest Medical Device Marketplace

October 31, 2017 – FRANKFURT, Germany – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO®) that accelerates medical device development through integrated laboratory, clinical research and regulatory consulting services is pleased to announce the launch of its newly developed German language website. The introduction of this highly-anticipated online resource will help support medical product … Continued

New Medical Device Classification Catalog Issued by the CFDA

At present, China has approximately 77,000 medical device registration certificates and 3.7 million medical equipment records, making the process of obtaining, tracking and managing classification documentation a rather large feat. On September 4, 2017, in an effort to simplify the classification process, the China Food and Drug Administration (CFDA) introduced a new version of the … Continued

NAMSA Announces New Online Test Selection Tool to Support Global Medical Device Manufacturers

TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical and consulting services is pleased to announce its newly-released online test selection tool, NAMSA Test Navigator, to fully support global medical device manufacturers’ testing requirements.  The Test Navigator was built to provide … Continued

Japan’s PMDA Consultation Offering: A Beneficial Resource for Streamlined Device Approval

As any device manufacturer is aware, medical products throughout the globe are regulated according to each device’s targeted country of distribution. While conventional and/or equivalency products typically have a clearcut regulatory pathway, new or improved medical devices are often comprised of time-intensive and sometimes confusing regulatory approval routes. This is especially true for multinational manufacturers … Continued

NAMSA Launches Japanese Website to Support Increased Demand for Medical Device Development Services

July 17, 2017 – TOKYO, JAPAN – (BUSINESS WIRE) – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical and consulting services is excited to announce the launch of its newly developed Japanese website. The introduction of this highly-anticipated website is a direct result of the increased … Continued

Focus on Japan Series: Part IV – Streamlining the Quality Management System Approval Process

Like several other geographies throughout the globe, the Country of Japan has its own Quality Management System (QMS) Ordinance for medical devices, which subsists of ISO 13485 requirements and additional country-specific standards. All medical products marketed and sold in Japan must be manufactured in accordance with these QMS requirements in mind. It is important to … Continued

China Releases Regulations for the Supervision and Administration of Medical Devices (No. 680)

On May 19, 2017, China’s State Council issued the “Supervision and Regulation of Medical Devices (No. 680),” just three years following the State Council Decree No. 650, which addressed similar regulations, including how medical devices should be supervised. While there are many parallels between the two regulations, there are three significant areas of change that … Continued

NAMSA Celebrates 50 Years of Scientific Innovation in the Medtech Industry

The world’s only Medical Research Organization (MRO) marks a half century of delivering superior results to global medical device clients and improving patient health. June 6, 2017 – TOLEDO, Ohio – NAMSA, the world’s only Medical Research Organization (MRO®) that accelerates medical device development through integrated laboratory, clinical and consulting services, will celebrate its 50th … Continued