blog
Digital Health Series – Part 1: Defining Software as a Medical Device
Recently, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has provided updates to the guidance Software and AI…
blog
Importance of Quality Management Review for Medical Devices
If you are an innovator developing a device, it is critical to understand the purpose and innerworkings of quality management…
blog
IVD Directive to IVD Regulation (EU 2017/746) Transition – 8 Months Remaining
IVD Regulation Postponement Today 14th October 2021 the European Commission has issued a Question and Answers press release on the…
publication
TOPRA/RAPS Workshop on Alignment of Global Combination Products
The TOPRA/RAPS inter-regulatory and stakeholder two-day workshop held in June 2020 focused on global combination product regulations. The diverse panel…
webinar
How to create an aligned global co-development strategy for drug with device component combination products
Drug delivery technologies are becoming increasingly complex and integrated, combining various advanced technologies with the intent to deliver the drug…
webinar
Medical Device Software Development: How to Build your EU/US Strategy
This webinar helps developers of e-health/m-health solutions to better understand the regulatory environment relevant to their digital technologies in Europe…
Case study
Taking the Pain out of Clinical Studies for Medical Devices
A French based research company were looking for guidance on developing a medical device to ensure MD safety validation. VCLS…
webinar
Changes and Impacts of the New EU IVD Regulatory Requirements with CDx Specifics
The new EU IVD regulation will introduce major changes that will greatly impact IVD product development and CE marking. These…
