Quality Assurance and Regulatory Affairs

Ensuring quality and compliance in healthcare

Ensuring Quality in Every Step

Supplier Quality Management

Our Supplier Quality Management team plays a vital role in ensuring the safety, reliability, and compliance of every product we deliver. We work closely with our suppliers to uphold rigorous quality standards from sourcing raw materials to the final product release. Through audits, qualification processes, and continuous monitoring, we make sure our partners share our commitment to quality. This helps us guarantee that the products you receive are not only effective but also manufactured under the highest standards of safety and integrity.

Prepared for MDR compliance

After five years of dedicated work, our QARA team successfully achieved full MDR compliance in May 2023, one year ahead of schedule. Today, every product for which Medline International France is the legal manufacturer is MDR certified. This milestone reflects our deep commitment to patient safety and regulatory excellence. MDR ensures stricter controls, greater transparency, and higher standards, reinforcing trust in the products we deliver every day.

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Our certifications

ISO 9001: 2015

Our offices in France, Italy, Spain and our warehouse in Germany are ISO 9001: 2015 certified. This certification enhances quality, boosts operational efficiency, and strengthens customer satisfaction and market opportunities—all while reducing risks through continuous improvement.

ISO 13485: 2016

Our manufacturing sites in Châteaubriant and Slovakia, along with our warehouses in Germany, are proudly ISO 13485:2016 certified. This certification demonstrates our ability to design, manufacture, and deliver safe, reliable medical devices while ensuring compliance with global regulatory standards, minimising risks, and expanding market opportunities.

View all our certifications

Contact us

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