As a medical device or IVD manufacturer, you probably registered your medical devices in the main medical markets (EU and US). However, more opportunities for improving market share are available outside these countries. You will be constantly pressed by management or sales to register in many countries where opportunities appear. Your team is already busy, and additional capacity is unavailable or lacks the expertise required for in-country representation, local regulatory insight, building registration files, and ongoing compliance support.

Registration in countries outside the main medical markets (EU, US) starts with understanding what documentation is needed and who can fulfill which role. Having EU certification or US approval can give you a head start in other countries' registrations. You need to understand the best route to compliance to accelerate market access. Each country requires local regulatory insight to navigate complex, region-specific requirements, understand cultural and procedural nuances, and keep pace with regulatory changes.

Qserve offers flexible capacity to support your team for a limited period until the registration process is finished. We can engage in several ways, from adding temporary personnel to turn key registration process.

Our experienced team has supported many device registrations over the years, giving us detailed expertise for market entry. We use a platform to keep track of all changes and guidance in the regulations, which is very helpful if you want to know upfront what needs to be done and also post-market to maintain the registrations in case of changes to the devices or regulations.