The importance of a robust Design and Development (D&D) process in medical device companies
In the competitive and highly regulated world of medical technology, a robust and well-structured...
Category: Medical devices
Tough times require sharp strategies – and the right expertise
The industry's financing climate has slowed down considerably. Investments in the development of...
Does the Health Technology Assessment Regulation (HTAR) include medical devices?
The Health Technology Assessment Regulation (HTAR), officially known as Regulation (EU) 2021/2282,...
Regulatory strategy vs. regulatory intelligence
Navigating the regulatory landscape of the medical device sector is a complex task, requiring both...
Does your device require a clinical investigation?
Are you developing a product intended to diagnose, treat, or prevent medical conditions? If so,...
5 steps for a successful clinical investigation
Setting up a clinical investigation for a medical device requires careful planning and a thorough...
Clinical investigations of medical devices: What's new in 2024?
New and exciting technologies emerge in the field of medical devices, and clinical data is becoming...
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A Clinical Study of Peili Vision’s EFSim Test Software
Peili Vision’s software aims to expedite the...