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On March 30, 2023, the U.S. FDA issued draft guidance outlining the use of Predetermined Change Control Plans (PCCPs) for AI/ML software.
On March 30, 2023, the U.S. FDA issued draft guidance outlining the use of Predetermined Change Control Plans (PCCPs) for AI/ML software.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 announced today its acquisition of SUAZIO, an EU-based strategic consultancy providing global market research services to medical device and IVD developers.
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, 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, 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 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 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, 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, 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.
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.
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®, 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, 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, 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.
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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