Maintaining Regulatory Compliance in Medical Devices through ISO 13485 and 14971 - Juniper Publishers
Cancer Therapy & Oncology - Juniper Publishers Abstract International organization of standardization (ISO) has the responsibility of forming international standards across the globe. The technical community of international organization of standards drafts international standards as per the rules and directive. Most medical device manufacturers use ISO 13485 as the quality management system to demonstrate their ability for consistency in design, development, and safe delivery for their medical devices and related services meeting regulatory compliance and customer needs. ISO13485: 2016 replaces the 2003 version and will be mandatory for device manufacturers to transition over within three years. ISO 14971 is a standard for risk management for medical devices. FDA terms it as acceptable whereas in Europe it is mandatory Keywords: ISO 13485:2016; ISO 14971; Medical device; Quality management system; Risk Abbreviations: ISO: International Organization of Standard