(BS) (EN) ISO 13485:2016 specifies requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Requirements of ISO 13485:2016 apply to organizations regardless of their size and regardless of their type, except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services supplied by the organization.
EN ISO 13485 is a parallel standard issued to create a QMS in the medical device industry in the European Union. The requirements of these two standards are identical, and the entirety of the ISO 13485:2016. However, EN ISO 13485 includes several invaluable tables that align the ISO 13485:2016 requirements to MDR 2017/745 and IVDR 2017/746. It is expected that a new version of EN ISO 13485 will be released soon.
ISO 13485 Certification is NOT mandatory for anyone who even applied for medical device product Certification. ISO 13485 Implementation is mandatory for CE Marking under MDR or IVDR.
ISO 13485 Regulatory consultants work to provide solutions to the client’s changing business needs and regulatory needs ( Country Specific) The consulting team’s knowledge and experience are often required to become aligned with a specific industry of their choice and eventually become error-free compliance.
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We work as regulatory advisors for the US Food and Drug Administration. Manufacturers may integrate both standards into a single documentation system with our help. Our ISO 13485 Consultants have worked on similar projects before and have dealt with FDA auditors.
