Qms System For Medical Devices

Qms system for medical devices for a medical device? It’s a task that is often delayed until later stages of development. Don’t wait to implement a QMS; the consequences of waiting too long can lead to irreparable damage to your processes and, in some cases, product failures. Medical Device manufacturers are faced with a wide range of quality and compliance challenges.

Compliance with UDI, eMDR, ISO 13485:2016, MDSAP, EU MDR, and other global regulations are constant requirements in a highly competitive marketplace. Staying on top of medical device compliance is challenging enough, but new programs like the FDA’s Quality Metrics initiative are pushing the industry toward data-driven Qms system for medical devices that focus on results.]

All through the process, finding the right Qms system for medical devices and understanding the standard procedures is of utmost importance. Here are some of the considerable effective QMS elements.

Documentation

The fundamental elements of a Qms system for medical devices are documents and processes, quality events, audits and workflows. Therefore, having a quality manual with various sections of relevant ISO standards (e.g.: ISO 13485) and understanding its requirements is important. A quality manual must meet the following criteria:

• Describe the scope of your QMS
• List the procedures comprising the QMS
• Describe interactions of QMS processes
• Outline the structure of QMS documentation

Medical Devices Files

A medical device file must be available for every type and family of the medical device with the following contents:

• Product description, including, intended use and indications for use
• Product labeling and instructions for use
• Product specifications
• Procedures and specifications for manufacturing, inspection, labeling, packaging, storage, handling and distribution
• Measuring and monitoring specifications
• Product installation specifications and procedures (if applicable)
• Product servicing procedures (if applicable)

Organizational Structure and Process

• Executive management should create and implement quality policy and quality objectives

• The organization must dedicate enough quality resources for training, audits and assessments

• A designated executive must be responsible for the QMS and quality system reviews

• Create a policy for quality audits, document the audit findings and use the audit results to trigger corrective actions

• Hire the right and sufficient personnel with relevant experience and provide effective training

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