Medical Device

MPCC is a regional leading medical device consultancy firm, offering a range of services in Medical Devices Management System, including a full spectrum of regulatory affairs.

Assisting the local companies to register the Low-Risk Medical Devices in Saudi Food & Drug Authority (SFDA) and Getting their Establishment License. Registering the Authorized Representative, and Getting Marketing Authorization for the medical device. We classify products as well as Getting the importing & exporting permission from SFDA.

We have proven regional expertise, provide comprehensive solutions, focus on robust services that makes us a trusted leader in Medical Device Services.

MPCC provides Medical Devices Certification

• Initiate ISO 13485:2016 Certificate that is approved by Saudi FDA
• Prepare QMS documentation system according to ISO 13485:2016
• The organization data is recorded on the certification body (IAF) website, immediately upon receipt of an electronic copy of the certificate.