Starting a company within the regulatory field of medical devices contains a long series of restrictions, which at times can seem challenging.
In our 2 Episode of our Qmed Consulting Podcast (Season 2), we get an insight of Victor and Andreas, experience within the Quality Management System.
The two engineers have developed a Class IIa medical device. The device measures the amount of oxygen within a child under labor. It prevents unnecessary C-sections, and any complications of birth there may occur.
The Qmed Podcast gives an understanding of how to navigate in an early start-up phase of EQMS.
All seasons and episodes are available on your favorite podcast platform.
Clinical Data & Analytics
Clinical Evaluation Report
Clinical Investigation for Medical Devices
Clinical Research Organisation
Clinical Trial Management
Clinical Trial Management Systems
Clinical Trial Services
Data Management
PMCF Studies
Post-Market Studies
Clinical Development
Clinical Evidence Strategy
Clinical Study Design
Clinical Trial Regulatory Requirements
EU MDR Consulting
ISO 13485 Consulting
ISO Standards for Clinical Research
IVDR Consulting
Medical Device Classification
Medical Device Regulatory Strategy
Post-Market Surveillance
PSUR
Quality Management
Risk Management
Technical Documentation
UDI & EUDAMED
