April 2020 - VigilanX

Post-market surveillance (PMS) system of the manufacturer

Posted on 5. April 2020 by mactech

The PMS system must be documented and implemented within the manufacturers’ QMS. The PMS should be risk-based according to the products manufactured. The PMS system must be suitable to gather, record and analyse the relevant data. It should be done in accordance with the control strategy of the manufactured product to gather relevant data regarding […]

MDR Compliance Process

Posted on 30. March 2020 by mactech

Below you will find a general process for MDR Compliance. There are amended and new classification rules. Some producers might find their products grouped in higher risk classes under the MDR. There will be an extended version of the Essential Requirements, now called the General Safety and Performance Principles or Requirements (SPR). Also, the provisions […]