ISO 13485 Implementation refers to the process of establishing, documenting, applying, maintaining, and continually improving a Quality Management System (QMS) in accordance with the requirements of the ISO 13485 standard. This standard is specifically designed for organizations involved in the design, production, installation, and servicing of medical devices and related services.
At MD QMS, we specialize in transforming medical device companies through the strategic implementation of ISO 13485. With a dedicated team of experts, we bring a wealth of experience and a personalized approach to every project.
Our Offer
We don't just implement a standard system; we develop a Quality Management System (QMS) tailored to your unique processes, products, and goals.
From quality manuals to detailed procedures, we ensure your documentation is robust, clear, and compliant.
Our approach embeds risk management throughout your product lifecycle, aligning with ISO 13485's focus on patient safety and product quality.
Navigating the complex landscape of medical device regulations is our forte. We ensure your QMS complies not only with ISO 13485 but also with relevant regional regulations.
We equip your team with the knowledge and skills to effectively maintain and improve your QMS, fostering a culture of quality and compliance.
Our service extends beyond implementation. We provide strategies and tools for ongoing improvement, ensuring your QMS evolves with your business and the industry.
We prepare you for internal and external audits, ensuring confidence and compliance at every step.
Why us
