Go to Client Portal

EU MDR Poses Significant Changes for Importers and Distributors

The European Union’s (EU) Medical Device Regulation (MDR), officially passed in April of 2017, may cause significant changes to the regulatory obligations of legal manufacturers, importers and distributors involved in the medical device distribution chain. The new MDR regulations differ significantly from the current EU Medical Device Directive (MDD) and go beyond design, development and … 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