compliance

By combining our expertise, technology, and industry knowledge, NVS helps you to focus on what you do best — designing, commercialising, or sourcing medical and health devices — while we take care of your regulatory needs.

We are committed to maintaining the quality management system's effectiveness through reviewing quality objectives and compliance with regulatory requirements.

Bringing to market your medical device requires obtaining registration and approval from regulatory bodies in each country where you want to sell your products. Device registration regulation and dossier can vary significantly from country to country, leading to compliance challenges for firms looking for a global market presence.

Successful registration means significant effort to meet pre-market technical and clinical submission requirements or employing your existing registrations and approvals to get faster access to new markets.

Our experts provide device registration and regulatory compliance assistance in established markets such as the US and Europe, and emerging markets, including the US, CIS, India and others.

We are commited to a higher standard because that’s what our customers deserve. NVS complies with quality management benchmarks and international standards in all aspects of our work.

Our global quality assurance team ensures system-wide regulatory compliance on the local, regional and corporate level.

Our team and project managers keep track of regulatory changes in all markets where we work, making sure your pre-market application meets the most up-to-date requirements, clearances and approvals.