Medical Device Management & Consulting consulting@regpromedical.com +1 (425) 241 - 3092
RegPro Medical
We know WHAT to do. We do it RIGHT. The FIRST Time.
Regulatory Strategy
Your regulatory strategy is your roadmap to getting your medical device on the market in the places you want to sell it. Careful planning will minimize cost and maximize efficiency. Approval or registration in one jurisdiction can facilitate the approval process in others. For example, CE certification will be recognized in UK, Switzerland, and Turkey, and also streamlines the registration process in Australia, Saudi Arabia, and many other jurisdictions. Additionally, EU MDR specifically requires a documented strategy for regulatory compliance to meet the requirements for CE marking. The cost and effort involved will depend on the risk level and classification of your medical device, and the markets you select for initial launch and later expansion into.
What will RegPro Medical Do?
RegPro Medical will help you to plan the regulatory strategy you need and how to achieve it as your startup launches. Getting the right systems in place at the outset will save time and money now and increase profitability in the long run.
If you have an established product expanding into the EU or need an overall roadmap for growth and expansion into any number of new markets, RegPro Medical will partner with you to construct an organized and detailed regulatory strategy to meet your goals.