Ensuring a smooth MDR transition for Oystershell's medical devices

Oystershell

Clinical, Regulatory Affairs

Medical Devices

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The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.

About 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.

1

Challenge

2

Approach

3

Result

Challenge

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 is proactively allocating additional resources towards compliance with the Medical Device Regulation (MDR) requirements. This strategic focus is essential for securing (or renewing) the CE certificate for medical devices, ensuring both new and existing products meet the highest standards.

Approach

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 experienced team members to Oystershell, we ensured a seamless, efficient, and comprehensive approach to compliance and regulatory excellence.

Result

A pathway to compliance

The program successfully updated multiple technical files for Oystershell’s medical devices, ensuring that each file contains all the necessary documentation for full compliance with the Medical Device Regulation (MDR). This comprehensive documentation affirms Oystershell’s commitment to adhering to regulatory standards and underscores the readiness of its products to meet the highest quality and safety benchmarks.

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.

Get in touch

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.