Episode Synopsis "S5 E3: Academy Talks: Medical Device Documentation: Requirement Specifications"
Now that you have your user needs description, we will walk you through how to set the user and device related requirements supported by the list of applicable standards and the device description. Once we have this in place, we will be able to define our clinical claims and clinical and non clinical objectives, Again, we highlight the importance of updating the ongoing documentation throughout the development process.
Listen "S5 E3: Academy Talks: Medical Device Documentation: Requirement Specifications"
More episodes of the podcast The Qmed Podcast
- BONUS EPISODE: Structured Dialogue: A Conversation with TÜV SÜD
- S5 E8: Academy Talks: Medical Device Documentation: Post Market Surveillance
- S5 E7: Academy Talks: Medical Device Documentation: Clinical Studies
- S5 E6: Academy Talks: Medical Device Documentation: Pre-clinical testing, Verification and Validation
- S5 E5: Academy Talks: Medical Device Documentation: Clinical Evaluation
- S5 E4: Academy Talks: Medical Device Documentation: Risk Management
- S5 E3: Academy Talks: Medical Device Documentation: Requirement Specifications
- S5 E2: Academy Talks: Medical Device Documentation: User Need
- S5 E1: Academy Talks: Medical Device Documentation: Stand Alone Documents
- Academy Talks: Medical Device Documentation
- S4_E2_PMCF survey with CETAS Healthcare
- S04 E01 Biocompatibility with Ted Heise
- S03 E05 - Usual Audit Findings During Medical Device Clinical Studies w. Rikke Boege
- S03 E04 - Clinical Investigations w. Susanne Dr. Gerbl-Rieger
- S03 E03 - The Benefit-To-Risk Assessment w. David Rutledge
- S03 E02 - Digital Health & Reimbursement
- S3 E01 - Sufficient Clinical Evidence
- S2 E18 – The Risk-Based Approach in Risk Management
- S2 E17 – Navigating Through CAPA
- S2 E16 - The Clinical Evaluation Pathway
- S2 E15 - The IVDR Transition
- S2 E14 - How to: EUDAMED
- S02E13 - Conducting Clinical Studies at Hospitals
- S02E12 - Submissions in Norway
- S02E11 - Submissions in Denmark
- S02E10 - Market Access with Søren Underbjerg
- S02E09 - An Update on EudaMed w. Richard Houlihan
- S02E08 - How to prepare for the upcoming changes with Norway Health Tech
- S02E07 - With Lasse Staal from AddiFab
- S02E06 - With Ernesto Nogueira from ValueConnected
- S02E05 - With Rasmus Lou-Moeller from Meggitt Denmark
- S02E04 - with Monir El Azzouzi from Easy Medical Device
- S02E03 - with David Rutledge from Global Strategic Solutions
- S02E02 - with Victor Staalkjaer and Andreas Tuxen from June Systems
- S02E01 - with Bjørn Broby from Neurescue
- The Qmed Podcast #10 with Helene Quie
- The Qmed Podcast #9 with Heidi M. Mehrzad
- The Qmed Podcast #8 with Richard Houlihan
- The Qmed Podcast #7 with Charlotte Piester
- The Qmed Podcast #6 with Ernesto Nogueira
- The Qmed Podcast #5 with Dr. Bassil Akra
- The Qmed Podcast #4 with Sandra Ferretti
- The Qmed Podcast #3 with Gert Andersen
- The Qmed Podcast #2 with Semih Oktay
- The Qmed Podcast #1 with Hilde Viroux