SERVICES
QMS
Expertise in building, developing and implementing Quality Management Systems for Medical Device organizations (Certifications to ISO13485, Adherence to CFR 820 & other country requirements)
CE
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
Design/Risk
Set up of Design Control/Risk Management Processes for Medical Devices
Auditing
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
MDR/ISO:13485
Gap Analysis, remediation plans for ISO13485:2016 standard
New Medical Devices Regulation (MDR, 2017/745) - Gap Analysis, Remediation planning & project management support
PMS/Vigilance
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
Development/Engineering
End to end services for Design & Development of devices