ISO13485: 2016 Quality Management Services
Medical Device
EOMI Consultancy Services (ECS) provide consultancy services to help medical devices companies with creation and implementation of ISO 13485 quality management system in compliance with UKCA and CE marking regulations. We provide total support for forming the Quality Management system in line with UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), European Union’s MDR 2017/745 and MDR 2017/746.
UKCA & Medical Device Regulation - 2017/745 QMS Transition
At EOMI Consultancy, our lead certified Auditor consultants can support your organization if you are ISO 13485:2016 compliant to MDD93/42EEC and MDR 2017/745. We can assist with the transition by carrying out a gap analysis of your Quality system in an efficient and compliant way.
The transition of MDR 2017/745 isn’t restricted to shifting QMS procedures, but likewise requires the establishment of systems for collecting PMS/PMCF data, analysing Clinical Evaluation Report data, controlling DHF documents, documenting updates to Risk Management Files and maintaining a UDI database.
We can also aid in your selection of a certification body and take responsibility for managing the audit process, reducing stress on your part.
For further details, please Contact Us