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Medical Device Quality Management System

Medical Device Quality Management System Overview

Medical Device Quality Management System(MD QMS)

Medical Device Quality Management System (MDQMS) is a systematic procedure and process covering all aspects of design, manufacture, and distribution. Quality management systems for medical devices are essential for ensuring compliance with various regulatory requirements. MDQMS is required for all medical devices, and its complexity will vary depending on the risk class of the device.

Most regulatory authorities across the world mandate the proper implementation and maintenance of medical devices quality management systems requirements for regulatory purposes. For placing medical devices in the European market, manufacturers must comply with ISO 13485, while companies looking to sell their products in the USA must adhere to the Quality System Regulation (21 CFR 820).

Under the new European Regulation (EU MDR), it is now obligatory for even manufacturers of low-risk class devices to have a basic QMS in place. Additionally, compliance with EMDN EUDAMED is crucial for tracking and managing regulatory submissions within the European market.

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ISO 13485

ISO 13485 is the most widely used standard for Medical Device Quality Management System issued by the International Organization for Standardization (ISO). ISO 13485 is based on the principles of ISO 9001, i.e., plan, do, check, and act. It differs from ISO 9001 in two important ways:

  • More emphasis on risk management
  • Additional requirements for documented procedures

Complying with the requirements of ISO 13485 provides a practical foundation for manufacturers to address EU MDR, EU IVDR, and other regulatory requirements. ISO 13485 was written to support the designers, manufacturers, and distributors of medical devices by ensuring they meet medical devices quality management systems requirements for regulatory purposes.

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 also full quality management systems for medical devices throughout the entire life cycle of the medical devices they manufacture.

ISO 13485 and CE Marking

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..

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Benefits of having ISO 13485 certified quality Management System

  • Improve company’s credibility and image
  • Improve customer satisfaction
  • Improve your process
  • Improve decision making
  • Create culture of continued improvement
  • Better employee agreement
  • Compliance to multitude of regulatory requirements

What We Do

We understand our customer’s business and mission, striving to continuously innovate and enhance their quality management systems for medical devices. Our goal is to improve QMS, technology, and business processes while leveraging advanced data analytics to optimize operations and drive continual improvements.

Our mission is to build transparent, fully integrated, and compliant systems that support all aspects of business functions.

With a team of highly experienced and knowledgeable consultants, we independently and objectively assess existing quality systems, identifying gaps or deficiencies. Our experts provide valuable insights to optimize systems, ensuring high-quality outcomes.

If you lack the staff or resources, we also offer third-party internal quality system audits to help maintain compliance and efficiency.

Navigating CDSCO, European Regulations, and US FDA Regulations can be complex, but we stand by you as a trusted partner. Additionally, we support businesses in adopting medical device quality management system software to streamline regulatory compliance and quality assurance.

What-We-Do

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