ISO 13485:2016


We work with many clients on producing a new Quality Management System (QMS) including Quality Manual, Standard Operating Procedures (SOPs), Forms and Work Instructions in order to attain ISO 13485:2016 Certification. This includes working with clients producing medical device, in-vitro device and software/apps.


We can also help your organisation upgrade your entire QMS whether from ISO 9001 to ISO 13485 or to comply with the forthcoming Medical Device Regulation 2017/745 due to be introduced in May 2021.

Call us now 07933 545 591