Laboratory Test Request

Compliance Testing of Anti-Snoring Mouthpiece to EU Standards

Project Description

Third-party independent laboratory needed to conduct chemical analyses to ensure all materials in the anti-snoring mouthpiece are free from prohibited substances under European Union (EU) regulations.
- Test for biocompatibility according to ISO 10993-1 (Biological evaluation of medical devices), ensuring that materials are safe for prolonged contact with mucous membranes and skin.
- Regulatory Compliance Review: Review all documentation and product labeling to ensure compliance with the Medical Devices Regulation (MDR) 2017/745.
Deliverables: Detailed reports of material analyses and biocompatibility testing.

The aim is to ensure that our anti-snoring mouthpiece meets the stringent material safety and performance standards required to verify that the product is safe, effective, and compliant with all relevant EU regulations, including REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances).

Project Information

Number:24-00914

Industry:Medical Devices

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