ISO 13485:2016 Assistance

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).

Manhattan Global’s expert regulatory consulting team will assist with ISO 13485 requirements and certification. Our solution partners have over 25 years of experience of working with global medical device manufacturers in quality management and processes.

Benefits of EN ISO 13485 certification

Medical devices (including Class I) greatly benefit from a production line, that includes an internationally recognized EN ISO 13485 certified quality management system (QMS). The certification framework provides for more product opportunities and extensive market access approval. Manufacturers and sub-contractors of medical devices can leverage their certified QMS status for a seamless transition into specialized certifications such as TCP, MDR, IVDR and MDSAP. Start-up businesses benefit from the strong position EN ISO 13485 certification provides for future growth and expansion. Mindful preparation for the audit can also serve as an opportunity for all those in the medical devices industry to further refine QMS processes and workflows.

You will also be able to use your ISO 13485:2016 certification if you are suppliers or external parties that provide product, including quality management system-related services to such organizations.