In this webinar, we will explore the challenges associated with the technical documentation of Device Parts used in Drug-Device Combination Products through the analysis of real-world case studies, highlighting the most common issues and lessons learned across the industry.

In the first part, we will examine the regulatory framework and key requirements of Article 117, with a specific focus on the most frequent documentation deficiencies that can delay the regulatory review process.

In the second part, we will present a strategic approach to addressing these challenges, providing practical tools and methodologies to prevent documentation gaps and ensure full compliance with regulatory requirements.