Quality Management System for Medical Devices and IVD

Quality Management System (QMS)for medical devices & in vitro diagnostics

At MDRA, we recognize that a strong Quality Management System (QMS) is fundamental to guaranteeing the quality, safety, and effectiveness of medical devices and in vitro diagnostics (IVD).

Whether you are navigating the intricate UK and European markets or seeking to expand your presence globally, our QMS expertise is customized to address your specific requirements.

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How We Work

Our Proven 3-Step QMS workflow

We deliver efficient, compliant  QMS with collaborative process designed to maintain the QMS Certification for your business operations.

1. Customizing Your QMS for Success

Understanding the unique infrastructure of your organization is crucial for developing and implementing an effective Quality Management System (QMS). Our QMS development process includes a comprehensive analysis of your operations, ensuring that your QMS integrates smoothly with your daily activities. By customizing your QMS to meet your specific needs, we enhance efficiency, quality, safety, and reliability in your devices.

2. Continuous Support for Success

After the implementation of your QMS, ongoing support is vital to keep it up-to-date and compliant with relevant standards. Our support services encompass reviewing and updating procedures, performing internal and supplier audits, managing non-conformances, executing corrective and preventive actions, and addressing complaints. We ensure that your QMS remains strong and flexible.

3. Enhancing Your Quality Management

At MDRA, we offer advanced support to drive systemic improvements within your organization from the ground up. Reach out to us today to discuss your needs and discover how our QMS expertise can enhance the quality, safety, and compliance of your medical devices.

Comprehensive Quality Management System

MDRA delivers variety of compliant Quality Management Systems

21 CFR Part 820, Quality System Regulation (QSR)

For those targeting the US market, compliance with 21 CFR Part 820, known as the Quality System Regulation (QSR), is essential. This entails establishing and maintaining a quality system to guarantee that your medical device meets the relevant requirements and specifications. Our expertise in this area helps you navigate the specific requirements of the FDA, ensuring that your products can successfully enter the expansive US market.

ISO 13485:2021

ISO 13485:2021 is an internationally recognized standard that provides a solid framework for developing and sustaining your quality management system for the UK, US and European markets. This standard is also acknowledged in various global markets, offering a strong basis for achieving compliance and excellence.

Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) simplifies your QMS by utilizing a single audit process that meets the requirements of multiple regulatory jurisdictions. This program includes countries such as the United States, Canada, Brazil, Australia, and Japan. MDSAP is based on ISO 13485 as its framework, while also integrating country-specific regulatory requirements, including market authorization, registration, and adverse event reporting. It streamlines the intricate landscape of global compliance without compromising the product-specific approval or registration requirements in each individual country.