Medzus | Quality Assurance & Quality Control
Open

Quality Assurance & Quality Control


Medzus Medical always focuses on quality; hence quality process starts right from the raw material sourcing to finishes at customer satisfaction. Medzus operates a quality management system compliant with the requirements of ISO 9001:2015 & ISO 13485:2016. Comprehensive & rigorous quality inspection using physical, chemical, biological &microbiological testing at raw materials stage, during in-process & on finished product helps us in transferring 100% clinically safe products. Well defined & documented Product Design Dossier & quality assurance procedures, protocols & reports help us in getting fastrack product approval with various regulatory authorities.

Medzus Medical routinely follows & implements the updated regulatory and quality assurance requirement guidelines set by the medical & health regulatory domains around the globe.

Quality Policy

Being serves to medical field, it is our quality policy to consistently provide a quality products and services to our customer with affordable & cost effective line, and also committed to improve customer satisfaction by continual improvement with the mean of thoughts as -

To follow the requirement of medical device directive and any other statutory & regulatory requirements,

To perform routine monitoring, control & calibration of critical process parameters & instruments,

To perform required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance,

To incorporate strong Quality Assurance team to achieve quality objectives of Good Manufacturing Practices & Good Laboratory Practices,

To implement the quality management system and monitor its effectiveness,

To provide training to all workers on works they performing,

To provide all workers Medical Device Directive and ISO 13485:2016 education in the orientation process,

To build resources for continual improvements- Human Resources, Infrastructure, Work Environment, To perform the Risk Management,

To perform Post Market Surveillance, customer communication & implement the medical experts suggestion,