Ten Elements for a Streamlined Digital Regulatory Future
Topic : Regulation Type : Briefing
A new white paper from Veeva Systems, Ten Elements for a Streamlined Digital Regulatory Future, sets out a vision for modernising medical device and IVD regulatory submissions through a more efficient, data-driven approach.
Developed through a regulatory executive roundtable involving manufacturers, consultants, notified bodies, and trade associations, the paper argues that current document-based submission processes create unnecessary duplication, administrative burden, and inefficiencies across the product lifecycle.
The paper calls for a future framework that is based on structured, reusable data, supported by ten core principles including standardisation, interoperability, global harmonisation, AI enablement, lifecycle governance, and improved transparency. It also highlights the potential benefits for manufacturers, regulators, conformity assessment bodies, and ultimately patients through faster access to innovative technologies.
ABHI's Steve Lee was pleased to contribute to the roundtable discussions that helped inform the paper and its recommendations.