Regulatory bodies worldwide make use of consensus standards developed by independent organizations to establish best practices and conceptual harmony on specialized areas of expertise. Standards organizations for drugs include the regional Pharmacopeia USP, EP, and JP as well as industry associations such as the International Society of Pharmaceutical Engineers or the Parenteral Drug Association. For devices, the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) leap to mind, as well as the American Society for Testing Materials (ASTM) or Underwriters Laboratories (UL). Whether for-profit or nonprofit, specific to medical products or more broadly applicable, standards organizations create a common understanding across their target communities, enable information sharing, and facilitate the economic and regulatory transactions necessary for global access to safe and effective treatments.
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