blog
Software as a Medical Device Regulated by the US FDA
Artificial Intelligence has achieved major milestones in the US, with the FDA granting clearance to the first AI-based software for…
blog
Selection of a Notified Body for Medical Device Development
In the European Union (EU) the review and approval of medical devices and in vitro diagnostic medical devices often requires…
blog
Digital Health Series: 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…
blog
Tips to Select the Right Notified Body
> SEE UPDATED ARTICLE In Europe, the review and approval of medicinal products involve Medicinal Competent Authorities from A to…
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…
