Podcasts
AI & Machine Learning in Medical Device
In this episode of ÐÓ°ÉÂÛ̳ Radio, host Erika Porcelli and guest Lisa Michels, General Counsel & Regulatory Affairs Expert at ÐÓ°ÉÂÛ̳ (ÐÓ°ÉÂÛ̳), examine the FDA's proposed regulatory framework...
Read More
Case Studies
CE Mark: Clinical Evaluation
Devicor, the leading breast biopsy device manufacturer, engaged ÐÓ°ÉÂÛ̳ to build a clinical evaluation process.
Read More
Case Studies
Production and Process Control
Background A Fortune 500 biotechnology company faced ongoing challenges during campaign changeovers due to missing parts critical to equipment assembly. These deficiencies frequently led to costly, last-minute part fabrication and...
Read More