Anyone submitting a premarket application or submission for a device classified as a “cyber device” must include information required by the FDA to ensure the device meets cybersecurity requiremen…
Technical Teams often produce a large percentage of their documents and Inefficiencies are introduced when teams create long and complex technical documents like GSPR, STED, regulatory documents (…
Where do authors spend most time that they hate. Easy guess, it’s Formatting and reviews.
In spite of process documents, templates, rule books, qc checklists, authors still spend lot of t…
Clinical trials are essential for evidence-based medicine, providing critical insights into the efficacy and safety of new treatments. One crucial aspect of conducting clinical trials is the rando…
Regulatory Impact Assessment (RIA) need not be fully integrated into the regulatory policy processes from the beginning. Companies can start by undertaking RIA for certain key regulations which ar…
