Seamless MDR Transition for Oystershell's Medical Devices
In the ever-shifting world of medical device regulations, staying ahead can feel like a daunting task. Our partnership with Oystershell, starting in July 2023, showcases our knack for turning complex challenges into success stories, all with a touch of QbD Clinical magic.
Oystershell
In July 2023, we partnered with Oystershell, a Ghent-based company that specializes in the development and marketing of product innovations in dermatology, lice and insect treatments, and mineral supplements. The project involves a scientific writer assignment.
Tackling the new EU MDR landscape
With the implementation of the new EU Medical Device Regulation (MDR) to replace the former Medical Device Directive (MDD), Oystershell faces significant challenges in ensuring compliance with the new regulatory requirements. Compliance with the MDR is required to obtain (or renew) a CE certificate for their medical devices.
Sounds familiar? We can help.
Expertise and dedication
The Medical Writing team at QbD Clinical has substantial experience in supporting clients during their MDD to MDR transition. By fully outsourcing one of our seasoned team members to Oystershell, we ensured a seamless, efficient, and comprehensive approach to compliance and regulatory excellence.
A pathway to compliance
The program resulted in the composition of a (draft) technical file for each of Oystershell’s medical devices. Each technical file contains all the necessary documentation to ensure compliance with the MDR. Currently, these technical files are prepared to be submitted to the Notified Body.
Face the regulatory maze with ease
The path to compliance doesn’t have to be complicated. Inspired by our successful partnership with Oystershell, QbD Clinical is ready to guide you through the MDR transition with ease and expertise.
Ready to ensure your medical devices meet the latest standards without the hassle? Let’s talk. Our Medical Writing team is here to simplify your compliance process and accelerate your success in the market.
Ready to ensure your Medical Devices meet the latest standards without the hassle?
Let’s talk. Our Medical Writing team is here to simplify your compliance process and accelerate your success in the market.