We recently got audited by CDSCO notified body for three different categories of medical devices for which we had applied for the manufacturing license under Form MD 5.
This category includes each medical device in each category. All three medical devices are manufactured for the first time in India.
On March 27, 2019, we applied for the endorsement for our existing manufacturing license for three medical devices.
To bring these products into our QMS system which is framed by the integration of 9001, 13485, New MDR 2017 and 21 CFR Part 820 QSR with four levels of documentation control, multiple processes including design, quality, and production have interacted together as per their responsibility to ensure that the required QMS documents and records are in place
We were audited by the CDSCO Notified body– Intertek India Pvt Ltd. And recommended by State Licencing Authority. An experienced Lead Auditor of Intertek, Mr Devendra Kumar Sharma – who was the Head of Quality and Environmental, Health and Safety (EHS) at India Medtronics, a medical devices manufacturer, audited our system in accordance with the audit criteria Fourth and Fifth schedule of MDR 2017.
The three-day audit agenda included the audit of Plant Master File, Device Master File, and QMS file.
The final day of audit ended with a closing meeting where the auditor highlighted his observations and improvements that can be implemented by us.
