Quality Management System Design

Rook’s team of quality engineers will create a custom QMS for your company that is both efficient and easy to maintain for your product and scope. Our systems are audit ready, and continually updated to ensure compliance with effective regulations.

What is a Quality Management System?

A Quality Management System(QMS) is based on the requirements of the US Quality System Regulation (QSR) 21 CFR 820, ISO 13485:2016 in order to demonstrate its ability to provide medical devices that consistently meet defined customer and regulatory requirements and its determination to enhance customer satisfaction.

We have custom QMS templates that will provide a clear path for you to create your device and maintain compliance. These templates are customized for each company to ensure they meet the needs and size of the company. Our templates are audit proven and can be implemented in your QMS in as quick as a few weeks. We have specific templates for all types of devices including the following

• SaMD Products including Agile Practices and devices with AI/ML
• Diagnostic templates specific for building and maintaining IVD products
• Electrical products meeting requirements for IEC 60601
• Templates for implantable and sterile devices including Class III products.

Benefits of a Quality Management System

There are several benefits to implementing a quality management system in an organization that produces or uses medical devices. Some of the key benefits include:

Traceability

Traceability shows records are established and maintained to provide evidence that the products, processes, and the quality system conform to requirements, and that the quality system is effective and efficient. This is a benefit because not only does it allow for organization but decreases the resistance during an audit or nonconformance.

Compliance

The benefits of compliance range from no fines, no recalls, no government agency audits, no warning letters, and protection from lawsuits. All of these benefits save time, money and decrease liabilities of the medical device company.

Benefits end user

The end user’s health, safety, and outcome is and should be the highest priority of the medical device developer. The end user’s safety is considered from the beginning with design control, risk analysis, and regulatory compliance. This allows the end user to trust the device they are using. Decreasing the liability and increasing the quality is a direct result of a strong QMS.

Increases companies worth (investors, buyers)

When a company has a well functioning QMS and hits their quarterly quality objectives and has documented evidence. This increases the worth of the company by showing its internal health and effectiveness. These records are easy to pull and display to a potential investor or buyer.

Overall, a quality management system can help organizations produce safe, effective, and reliable medical devices, which can ultimately lead to improved patient outcomes and better public health.

Quality Management System Experts

Rook’s team has experience customizing QMS templates for international regulations, including CE Mark under MDR, MDSAP, TGA, ANVISA, and other markets.

Our QMS templates are designed to take a clear approach to the regulations and focus on efficiency and simplicity. There is no need to over complicate the QMS especially with a small team. RookQS templates allow our clients to reduce the documentation burden and complexity while maintaining high quality and compliance.

In addition to creating your QMS, RookQS quality engineers can also maintain your QMS as a contract quality team; this includes yearly audit packages, management review, complaint handling, CAPA, and non-conformance management. We provide a full service QMS management team for small to large size companies managing your quality system as a service. Let Rook’s team grow and develop your QMS as your company grows!