Regulis obtains rapid CE marking

Regulis obtains rapid CE marking for a medical device that opens up a market worth $2.2 billon.

Situation

A US-based company had developed a Class III medical device for the treatment of hepatic cancer. The device had been designed to be used with a specific medicinal product. The company wanted to sell their product in the EU and the product must therefore carry a CE mark.

Challenge

To obtain a medical device CE mark, the manufacturer must submit a dossier of scientific and technical data to a Notified Body for assessment. They must also have a compliant Quality Management System (QMS).

Solution

Using our significant medical devices expertise and great commercial awareness, Regulis proposed to the client that their device be CE marked for use with chemotherapeutic agents in general rather than just the one the company had proposed.

  • Regulis liaised with the Notified Body to gain a CE mark with a broad use
  • Regulis helped the company generate and submit the correct information to get their CE mark application right first time
  • Regulis supported the company to implement a compliant QMS
  • Regulis gained approval for the company’s product in a short time.

Benefits

The Regulis engagement delivered:

  • Access to a market worth $2.2B
  • CE certification to permit sales across the EU.

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