Wireless remote intracranial pressure monitoring for medical diagnosis and treatment

Important results from the project

The goals of implementing the clinical evaluation plan and initiating the clinical investigation plan have been achieved. The project also contributed to increased knowledge of how the regulatory process has been for other medical device class 3 products for other global medtech products.

Expected long term effects

The project brings the project one step closer to product approval in the EU for medical implants for remote monitoring of brain pressure. The implant will be the first to be able to remotely monitor brain pressure in patients who need it in healthcare.

Approach and implementation

The project was carried out through regular meetings between project meetings which consisted of meetings and working meetings where we worked through and created the documents together. Brainlink, which develops the implant, provided technical specifications, eligibility requirements and "intended use" for the product, while Key2Compliance contributed valuable clinical regulatory knowledge.