MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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26 | July 2016 Standards Image courtesy of PETR73/iSTOCKPHOTO.COM I n March, the International Organization for Standardization (ISO) overhauled the long-standing ISO 13485 global stan- dard for medical device quality management systems. Device manufacturers are now as- sessing the ins and outs of the overhaul, ISO 13485:2016, and comparing and contrast- ing it to ISO 13485:2003. Manufacturers will need to make provisions to update their re- spective systems over the next three years to adhere to the new standard. Why did ISO update the standard? As the medical device industry continues to grow vigorously around the world, novel technolo- gies emerge that challenge the status quo and supply chains become longer and more complex. Global regulators, therefore, have sharpened their focus on the safety and ef- ficacy of medical devices. Since many regulatory bodies integrate ISO 13485 into their schemas, the impact of the updated standard is profound. It reflects the transformation of the industry, and it ex- pands beyond just the design and manufac- ture of devices. The updated standard pro- vides greater emphasis on risk management and quality throughout the supply chain and over the complete product life cycle, includ- ing postmarket surveillance and product dis- posal. Now organized into five major catego- ries, the details of ISO 13485:2016 reflect the changing nature of the medical device sector in the following areas: ■ Quality management system (QMS). ■ Management responsibility. ■ Resource management. ■ Product realization. ■ Measurement, analysis, and improvement. The broader reach of the new standard can be felt in its introduction, which indi- cates it can be used by "an organization in- volved in one or more stages of the life cycle of a medical device including design and de- velopment, production, storage and distribu- tion, installation, servicing and final decom- missioning and disposal of medical devices, and design and development, or provision of associated activities (e.g., technical support)." Device manufacturers, service providers, and supply chain partners are assessing their quality management systems with the aim of adapting them to the dynamic global en- vironment and easing regulators' concerns about device quality and performance. Let's explore some of the modifications contained in ISO 13485:2016 and the implications they pose for medical device manufacturers. The New Provisions of ISO 13485:2016 Regulatory. Industry experts and regula- tors alike contributed to the updated stan- dard with the intention of achieving greater harmonization of QMS solutions around the world and across different jurisdictions. Many nations already utilize ISO 13485, while others have modified their regulations to align with it. Greater harmonization aims to ultimately achieve a Medical Device Single Audit Program, currently being piloted by the International Medical Device Regulators Forum, which would allow companies to conduct a single regulatory audit of its QMS that satisfies the requirements of multiple geographies. This would ease the burden on manufacturers to satisfy multiple regulatory authorities with individual audits. ISO 13485:2003 required a medical device manufacturer to establish a QMS that com- plied with the standard. ISO 13485:2016, without naming specific jurisdictions, stipu- lates that an organization must identify its role as it relates to the regulatory require- ment, identify the regulations that apply to its activities, and incorporate those regulations into its QMS. In addition, companies must demonstrate the effectiveness of their QMS and utilize a risk-based approach to deter- mine its impact on product safety and perfor- mance. The application of risk also now ap- plies across the product life cycle rather than just during the design phase. Computer Systems Validation. Another change to the standard deals with the ap- plicability of computer systems validation. While the 2003 version of ISO 13485 speci- fied the validation of software for "produc- tion and service provision," the new standard specifically calls out the requirement for soft- ware used as part of the QMS. This extends the standard's reach beyond the production and service environment into the quality arena, which may present challenges to some organizations. In addition, ISO 13485:2016 now adds the application of risk to the vali- dation process, and mandates validation and revalidation be "proportionate to the risk as- sociated with the use of the software." Supplier Management. Due to the new The ISO 13485:2016 update will have a significant impact. Here's what medical device manufacturers need to know. BART REITTER

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