Ready for Launch: WQS Supports Rocket Dental in Bringing a Class I Dental Device to Market
WQS Management Consultants supported Rocket Dental in the regulatory implementation for a new dental product: RING, an intraoral lip and cheek retractor for use during dental examinations and procedures. The product is classified as a Class I medical device and is CE-marked.
Class I means that the manufacturer declares conformity on its own responsibility, without the involvement of a Notified Body in the process. Nevertheless, the documentation must be complete.
RING - The Revolution in Dental Retraction
A lip and cheek retractor holds back the lips and cheeks during treatment, creating a clear and easily visible working field. This is essential for precise work during examinations, restorations, and many other procedures. RING gives a panoramic view for the eye, the scanner, and the camera, and holds securely even during the bite scan. It comes in one size and is steplessly adjustable, for adolescents and adults alike. Placed in seconds, it holds without holding and keeps both hands free. Made from a single medical-grade polypropylene, delivered flat, three-dimensional in the mouth.
“For our first in-house medical device, we needed someone who not only knew the MDR requirements but also knew how to apply them. WQS handled the regulatory process from technical documentation through EUDAMED registration. We always knew what was coming next and why. Thanks to the WQS team for their reliable support.”
— Dr. Sebastian Horvath, Rocket Dental
Support from WQS
Technical Documentation in accordance with EU MDR 2017/745
WQS prepared the complete technical documentation for the product. It demonstrates that the retractor meets the essential safety and performance requirements of the MDR and forms the basis for the Declaration of Conformity.
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Risk Management
Every medical device requires a documented risk management plan. WQS systematically identified and assessed the product’s risks and transparently documented the measures taken to minimize them.
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Clinical Evaluation According to the MDR
Even a Class I product requires a clinical evaluation. WQS has prepared this in accordance with the requirements of the MDR and demonstrated the clinical benefit and safety of the retractor based on appropriate data.
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Packaging and Shelf-Life Testing
The packaging protects the product until it is used. WQS has conducted packaging and shelf-life testing, including accelerated aging, thereby ensuring the product’s shelf life under realistic conditions.
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Notifications and Registrations, Including EUDAMED
Notifications and registrations are required prior to placing the product on the market. WQS guided Rocket Dental through these steps, including registration in EUDAMED.
More on EUDAMED
Quality Management Documentation
Quality management requirements also apply to Class I devices. WQS has developed QMS documentation tailored to the product and its risk class.
More on Quality Management
From the initial product idea to a market-ready medical device: We thank Rocket Dental for their trust and collaboration. Take off successfully!
More about WQS Management Consultants and Rocket Dental.
