The medical device industry is highly regulated, and a well-implemented QMS may help you to navigate complex regulatory landscapes, minimize risks, and deliver safe and effective products to the market.
ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. It outlines the requirements for a QMS that demonstrates the ability to provide medical devices and related services that consistently meet customer and regulatory requirements. The main challenges include understanding and implementing the extensive requirements, maintaining compliance, and continually improving the QMS.
Having an effective QMS is crucial not only for regulatory approval but also for enhancing operational efficiency and keeping your product safe. Our medical device QMS consulting services are designed to help you develop, implement, and maintain a robust quality management system that meets ISO 13485 standards. We offer comprehensive support tailored to your needs, ensuring your QMS is effective and compliant. We can assist you with the following:
We handle quality management systems in multiple ways
What can we do for you
Our medical device QMS consulting services are designed to support you at every stage of the QMS lifecycle, from initial development through to certification and ongoing maintenance. Whether you are establishing a new QMS or seeking to enhance your existing system, we are here to ensure your quality management system is robust, compliant, and effective. We stand for creating a culture of quality and being proactively compliant.
Watch how we maintain the highest professional standards
Approach & Expertise
Learn how we can support you in meeting your business goals
- Our lean and powerful team with degrees in pharmacy, chemistry, biology, or related studies strive to be of added value to you. Our short reporting lines enable the most efficient road to your success.
- Having one point of contact from our experts backed by the team’s collective knowledge and resources we give reliable advice and execute projects seamlessly.
- At Starodub, consistency and assurance of quality are vital. A quality management system has been implemented and we adhere to GxP and ISO 9001/13485.