When: Wednesday, June 16, 2021 at 9:00 AM - 10:00 AM CDT
Where: Virtual (Register Here)
Cost: FREE
What: First, in a three-part series of webinars that Globiox will be hosting, each addressing different aspects of the new MDR / IVDR changes as they relate to medical device classifications, clinical evaluations, determining equivalency, and developing a post market clinical follow-up plan. The latest updates to EU MDR & IVDR place increased significance on clinical investigations by requiring all classes of medical devices to have a Clinical Evaluation Report.
This presentation will take a closer look at when CERs are required, requirements for Class I device filing and when you may need to have your QMS evaluated.
Key Takeaways · Clinical Evaluation Reports are living documents that require regular updates. · The Notified Body will judge the device based on the highest risk for the products intended use. · Transitioning from, or avoiding, a paper-based system can help ensure the highest level of control over your documentation and ease the audit process.
Speaker Bios Patti Rossman - An innovator and Globiox founder. 25+ years’ experience in FDA-regulated Quality, Compliance and Validation. 15+ years as a Quality Systems, Supplier, and Medical Device auditor. Certified Software Quality Engineer (CSQE-ASQ). Expertise with many Quality Systems, including GMP, GLP, GCP, DEA, EPA, EMA and ISO.
Mike Brillhart - A compliance professional with proven capabilities for project management and implementing quality standards and holds an extensive operations and engineering background. Highly knowledgeable in U.S. Food and Drug Administration (FDA), Corrective and Preventive Action (CAPA), medical devices, sterile injectables, Change Control, validation, and auditing preparations.
Globiox is a team of experts specializing in quality assurance, regulatory affairs, EQMS, and auditing for GxP in the Life Sciences. Offering FDA, REMS, ISO auditing, and Clinical Evaluations expertise.