Your approval strategy is the most important prerequisite for entering the market successfully. Although harmonization efforts are underway worldwide, medical device manufacturers must familiarize intensively with the approval specifics of each country; costs and time to market are important factors that must also be considered.
Our Regulatory Affairs team provides comprehensive advice on country-specific approval requirements, supports you in implementing them, and makes contact with your official bodies – for successful approval within the intended timing. We are looking forward to getting to know you!
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