#ISO 13485 FDA ISO#

Still, there are some use cases for ISO 13485, even within country-specific requirements. MexicoвЂ™s Norma Oficial MexicanaВ NOM-241ДЄn ISO 13485 certification is not a stand-in for the FDAвЂ™s or any foreign governmentвЂ™s region- or country-specific regulations but does serve as a common base for achieving specific compliance required by various customers and regulatory agencies.CanadaвЂ™s Medical Devices Regulations SOR/98-282.European UnionвЂ™s Directive for Active Implantable Medical Devices 90/385/EEC (to be replaced by EU 2017/745 on May 26, 2021).European UnionвЂ™s Directive for In Vitro Diagnostic Medical Devices 98/79/EC (to be replaced by EU 2017/746 on May 26, 2022).

European UnionвЂ™s Medical Device Directive 93/42/EEC (to be replaced by EU 2017/745 on May 26, 2021).

While we are focusing on 21 CFR 820 due to its application in the U.S., it is important to note that other countries and regions have specific guidance for quality management system regulations, including: Therefore, a quality management system that conforms to ISO 13485 does not automatically conform to ISO 9001, which would require separate certification. While ISO 13485 is based on ISO 9001, it excludes certain elements of ISO 9001 that are not deemed as regulatory requirements - such as the emphasis on continual improvement and customer satisfaction. In a nutshell, ISO 13485 goes a step beyond 21 CFR 820, which regulates finished medical devices to be sold in the U.S., by setting a global standard with specific guidance on how quality systems shall operate. In addition to device manufacturers, these standards can also be adopted by third-party suppliers that provide products and services along the device lifecycle, including raw materials, subassemblies, sterilization services, distribution services, and quality management system-related services, among others. ISO 13485 is an international standard that вЂњspecifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g.

Iso 13485 fda