The Qmed Podcast
1) BONUS EPISODE: Structured Dialogue: A Conversation with TÜV SÜD
At Qmed, we believe in fostering open, collaborative conversations to address the challenges faced in the medical device regulatory space. That’s why we’re thrilled to share the recording of our recen...Show More
2) S5 E8: Academy Talks: Medical Device Documentation: Post Market Surveillance
As a startup company, post market surveillance can feel far away and not relevant, but key documents are of critical importance to develop during the device development process. The authorities expect...Show More
S5 E8: Academy Talks: Medical Device Documentation: Post Market Surveillance
08:54 | Dec 13th, 2024
3) S5 E7: Academy Talks: Medical Device Documentation: Clinical Studies
We discuss how to define the clinical study endpoints based on your defined safety and performance objectives and the clinical development plan during the clinical validation procedure. We walk throug...Show More
4) S5 E6: Academy Talks: Medical Device Documentation: Pre-clinical testing, Verification and Validation
During this session, we will walk through how to translate the requirement specifications into a verification and validation plan, including setting up bio compatibility studies, animal studies and be...Show More
5) S5 E5: Academy Talks: Medical Device Documentation: Clinical Evaluation
We will walk through the clinical evaluation process starting with the clinical evaluation plan and the literature search as the initial steps to identifying the clinical safety and performance object...Show More
6) S5 E4: Academy Talks: Medical Device Documentation: Risk Management
This session will walk you through the overall risk management process. Starting with the description on the risk management plan and how to work with the risk management analysis/HTM matrix. This pro...Show More
7) S5 E3: Academy Talks: Medical Device Documentation: Requirement Specifications
S5 E3: Academy Talks: Medical Device Documentation: Requirement Specifications
17:00 | Nov 8th, 2024
8) S5 E2: Academy Talks: Medical Device Documentation: User Need
9) S5 E1: Academy Talks: Medical Device Documentation: Stand Alone Documents
10) Academy Talks: Medical Device Documentation