Owing to the nature of medical devices, its commercialization in any country is regulated and cannot be sold without appropriate registration and approvals. Regulatory authorities in different regions of the world recognize different classes of medical devices (MD) depending on the complexity of their design, their performance characteristics and their potential for harm if misused. Governments implement policies and regulations to address all elements related to Medical devices, from its design, manufacture, and registration to post-market obligations and disposal, so that the public can have access to quality, safe and affordable products to use.
Every country has its specific requirement that needs to be fulfilled which can significantly vary and hence medical device manufacturers face challenge in complying with all these different regulatory requirements especially organizations that want to strategize to pursue multiple markets.
With a team of more than 50 employees who hold expertize in various medical device domains, we have successfully done medical device and IVD device registrations in the following countries, but not limited to
We at Maven constantly stay updated with the dynamically changing regulations and requirements and keep our clients who have used our services updated with any changes in respective regulations and also send across reminders when their registration are due expiry. We help business in achieving their fullest potentials and become global.
Maven ProfservJanuary 13th, 2023
The verdict is out! The ball is now...
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Transitioning to Regulation (EU) 2017/745 (MDR) and Regulation...
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