Regulatory strategy vs. regulatory intelligence
Navigating the regulatory landscape of the medical device sector is a complex task, requiring both...
Category: Article
Patient Safety: The Cornerstone of Healthcare
Happy World Patient Safety Day!
Data management in clinical investigations - Part 4: Statistical considerations for pivotal investigations
Medical device manufacturers planning their first pivotal premarket investigations for CE-marking...
Extension of the MDR transition period – do not stop working towards the certification!
The European Commission’s proposal to amend the transition time frames for certain Medical Devices...
Data management in clinical investigations – Part 3: Data traceability
Data traceability is a foundational principle for clinical investigations aiming to demonstrate the...
Why health tech startups should attend the Regulatory Essentials in Health Tech training series
Health tech startups may often run into problems when it comes to understanding the complex world...
Data management in clinical investigations - Part 2: General data protection regulation
Sensitive personal health data is being collected and processed in clinical investigations aiming...
Data management in clinical investigations - Part 1: Study variables
The high quality of clinical investigation data is critical for demonstrating the performance and...