What is formative testing?
Formative testing is continuous evaluation during product development. Its goal is to identify problems and improve the user experience as the development process progresses. In health technology, this means regular usability testing with prototypes and development versio…
When is CE marking mandatory for medical devices?
CE marking is mandatory for all medical devices placed on the EU market that fall within the scope of the Medical Device Regulation (MDR). The marking demonstrates that the device meets safety and performance requirements. The only exceptions are cu…
Clinical evidence for the EU market refers to scientific proof of a health technology product’s safety and efficacy in accordance with the MDR regulation. Requirements vary by device risk class and may include clinical investigations, literature reviews, or the use of existing real-world data. To ob…
Here is the English translation:
How to Build a QMS System for Medical Devices?
A QMS (Quality Management System) is an essential quality system for medical devices that ensures product safety and compliance with regulatory requirements. It includes documented processes, risk management, a…
Imagine launching a health technology product only to discover that healthcare professionals struggle with basic navigation, or that patients abandon the application after their first attempt. This scenario unfolds daily across the healthcare technology landscape, yet it remains entirely preventable…
The last week of January was intensive and rewarding for Clinipower, as we participated in the ManagiDiTH Winter School & Innovation Bootcamp 2026 at Laurea’s Otaniemi campus. The five-day event brought together approximately 100 international students, experts, and innovative companies to devel…
Product Development and Innovation Require Continuous Renewal, but Internal Processes Can Become Rigid
Student collaboration offers a cost-effective way to introduce fresh ideas into the organization and challenge entrenched ways of working. Cooperation with educational institutions serves both as …
Health technology development challenges demand far more than the knowledge of one expert alone. When an organization faces regulatory requirements, usability issues, or patient safety risks, a multidisciplinary team transforms the challenge into a manageable problem.
In this article, you will lear…
The Winter School programme offers companies a unique way to stand out as an employer in the health technology sector. When an organisation enables its employees to participate in an international training programme, it sends a clear and concrete message of commitment to personnel development and co…
