Welcome to Medaptivo
Get invaluable expertise and guidance to achieve compliance with the latest medical device regulations. So that safe and effective products find their way to where they are needed the most.
About Us
As a medical device consulting company, Medaptivo offers comprehensive regulatory and quality compliance solutions across a broad range of devices and classifications, from the pre-market to the post-market stages.
Our team includes former EU Notified Body staff with first-hand knowledge of the regulator’s expectations, channeling their expertise into helping companies of various sizes and complexities to obtain market access and effectively maintain post-market approval.
EU MDR Support for the MedTech Industry
The new EU MDR came into effect on 26 May 2021. The complex new regulation has had a great impact on the MedTech industry due to significantly increased requirements, which translate into higher costs and extensive need for resources for all medical device stakeholders. We understand the challenges this may have brought you and are here to help you with the planning and implementation of the new regulation.
We would be happy to offer a free consultation to better understand how we can support your transition to the EU MDR.