Technical standards play a crucial role in ensuring quality, safety, and compliance across the healthcare and medical device sectors. Yet, many professionals use standards every day without fully understanding how they are developed or how industry experts contribute to their creation.
This webinar will provide participants with a practical overview of the standardization ecosystem, from the development of technical standards at national, European, and international levels to their real-world application in healthcare and regulatory affairs.
Experts from the field will explore the role of UNI, the Italian standardization body, explaining how technical standards are created and maintained, and how professionals and industry associations actively contribute to the drafting of standards and reference practices. Through a firsthand case study on the development of UNI/PdR 140:2023, attendees will gain insight into the collaborative process behind technical documents.
The webinar will also highlight how technical and harmonized standards influence the daily work of Regulatory Affairs professionals, supporting compliance activities, market access strategies, and the demonstration of regulatory conformity.
The session will conclude with an interactive Q&A, offering participants the opportunity to engage directly with the speakers and discuss practical challenges and experiences.
Key learning objectives:
- Understand how technical standardization works in Italy, Europe, and internationally.
- Discover the role of industry experts and professional associations in developing standards and reference practices.
- Learn from a real example of participation in the drafting of a technical document.
- Explore the impact of technical and harmonized standards on Regulatory Affairs activities in the healthcare and medical device sectors.
- Gain practical insights into using standards as a professional tool for regulatory compliance and quality assurance
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
