Medical Device Quality Management System (MDQMS), is a systematic procedure and process covering all the aspects of design, manufacture, and distribution. MDQMS is required for all medical device and the complexity will vary with varying risk class of medical device. Most of the regulatory authorities across the world require proper implementation and maintenance of the quality management system. For placing the medical devices in European market, the manufacturer is required to comply with the requirements of ISO 13485 and companies who want to sell their products in USA have to comply with the Quality System Regulation (21 CFR 820). Under the new European Regulation (EU MDR), it is now obligatory for even the manufacturers of low risk class devices to have a basic QMS in place.
ISO 13485, is the most widely used standard for Medical Device Quality Management issued by International Organization of Standardization (ISO). ISO 13485 is based on the principles of ISO 9001 i.e. plan, do, check and act. It differs from ISO 13485 in two important ways:
Complying to the requirements of ISO 13485 provides practical foundation for manufacturers to address EU MDR, EU IVDR and other regulatory requirements. ISO 13485 was written to support the designer, manufacturer, distributors of medical devices.
Risk management is a core element of ISO 13485 certification. ISO 14971, the risk management standard is designed to be compatible with ISO 13485. It helps organizations meet the increasing global requirements and expectations to implement not only quality, but full risk management systems throughout the entire life cycle of the medical devices they manufacture.
ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Regulations. ISO 13485 certification is not mandatory CE marking medical device organization. ISO 13485 is harmonized to EN ISO 13485, which allows compliance of conformity to European device regulations..
Understand our customer’s business and mission. Continuously innovate and improve our customer’s QMS, technology and business processes. Use advanced data analytics to enhance business operations and draw continual improvements in the system.
It is our mission to build transparent, fully integrated and compliant systems that help support all aspects of business function
We have a team of highly experienced and knowledgeable consultants who can independently and objectively assess existing quality systems to identify gaps or deficiencies. The Consultants provide valuable input into optimizing systems to ensure a high-quality output.
We can also perform Third party internal quality system audits if you do not have the staff or resources to do so.
We understand that becoming conversant with CDSCO, European Regulations and US FDA Regulations can be very challenging and we can be your companion in facing it.