Expertise in building, developing and implementing Quality Management Systems for Medical Device organizations (Certifications to ISO13485, Adherence to CFR 820 & other country requirements)


Management of CE certifications for Medical Devices, interaction with notified bodies, competent authorities, management and hosting of regulatory inspections

Part 4 (FDA 820)

Proven experiences in building and demonstrating compliance to the 21 CFR Part 4 legal requirements of Good Manufacturing Practice (cGMP) for combination products in the US


Set up of Design Control/Risk Management Processes for Medical Devices 


Qualified supplier auditing within the Medical Device and Pharmaceutical (GMP) industries 

Perform mock inspections pre ISO13485, FDA inspections

Support preparation & pre-inspection

Qualified Person

Qualified to Act as 'Person responsible for regulatory requirements (article 15 new MDR)' as per the new Medical Device regulations


Ad hoc onsite Regulatory/Quality Support


Gap Analysis, remediation plans for ISO13485:2016 standard


New Medical Devices Regulation (MDR, 2017/745) - Gap Analysis, Remediation planning & project management support


Post Market Surveillance, Complaints/Vigilance set up and support

Please get in touch to find out if our services can help your company achieve more

+44 (0) 79317 08332


End to end services for Design & Development of devices