ISO 13485:2016 is a standard
that sets out the requirements for a quality management system specifically for the design and manufacture of medical devices. It is intended to help organizations in the medical device industry to consistently provide medical devices that meet customer and regulatory requirements, and to enhance customer satisfaction through the effective application of the system, including processes for continuous improvement.
A consultancy is a company or individual that provides expert advice, guidance, or assistance to businesses or organizations in a particular field or area of expertise. In the case of ISO 13485:2016, a consultancy could provide support to a medical device company in the process of implementing and maintaining a quality management system that meets the requirements of the standard. This could include helping the company to understand the requirements of the standard, providing guidance on how to effectively implement and document the system, and assisting with the process of obtaining certification to the standard.