We can help you attain ISO 13485:2016 certification, an international standard that defines quality management system (QMS) requirements for manufacturers of medical devices.
This standard is essential for manufacturers of medical devices and to those organisations that support medical device manufacturers. Manufacturers have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements and accreditation to ISO13485 will help ensure that happens.
We can also offer assistance with:
FDA audit preparation
General advice on quality and regulatory aspects of medical device manufacture
We support multiple organisations in the medical sector and take on projects of any size.