ISO 13485:2016 Specifically for Medical Devices is an internationally recognized standard and provides best framework in setting up a quality management system to those organizations who are involved in the design, production, installation and servicing of medical devices and related services.

If you do not have a quality management system in place, all our consultants are ISO 13485:2016 lead auditor trained. We have a wealth of experience in putting Quality Systems in place for companies.

Please contact Sushvin for more information.

If your organization has ISO 13485: 2016 compliant to MDD93/42EEC but requires support with MDR 2017/745, All our consultants at Sushvin are lead Auditor trained and can help you perform a gap analysis for your Quality system and get the transition done in an easy and compliant way.

MDR 2017/745 transition is not only about changes in the QMS procedures but also setting up systems for PMS/PMCF data collection, Clinical evaluation report data analysis, DHF document control, Risk management file updates recording and UDI database maintenance.

We can also help you select a certification body and manage the audit process for you, so that you have one less thing to worry about.

Please contact Sushvin for more information.