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Month: August 2018

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

Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard

Risk management is an important lifecycle product development requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products. To appropriately address issues of potential risk within the European Economic Area (EEA), manufacturers must utilize the harmonized standard, EN ISO 14971:2012, to meet regulatory requirements. However, EU device manufacturers often struggle to … Continued