Regulatory and market access consulting services for MedTech, IVD and digital health companies.

EpisKey Medical can be an invaluable tool for e-health solutions companies looking to obtain CE marking for their innovative products. Here are some ways we can help:

Risk Management: EpisKey Medical can assist in identifying and managing the risks associated with digital health products. This is crucial for meeting the safety and performance requirements of CE marking.

Regulatory Compliance: We can provide guidance on the specific standards and regulations that apply to medical devices and digital health solutions in the European Union. EpisKey Medical can help in creating and managing the documentation needed to demonstrate compliance with the requirements of the Medical Devices Regulation and the in Vitro Devoces Regulation.

Quality Management: We can facilitate the implementation of quality management systems, such as ISO 13485, which are essential for obtaining CE marking.

EpisKey Medical can provide access to experts in medical device and digital health regulations who can offer personalized guidance on how to effectively and efficiently meet CE marking requirements.