Expect to see slow growth and more mergers & acquisitions.
Ernst & Young’s Pulse of the Industry report is out, and once again, it’s not all gloom and doom.
CDRH’s Carl Fischer shares the agency’s approach to organizing and managing complaints.
Many companies are unsure of how to complete a complaint investigation when the service and repair process is involved.
Getting into the mindset of an FDA investigator during an inspection is not necessarily easy.
Learn about the current guidance for Cybersecurity in the medical industry and strategies for how you can demonstrate to regulators, purchasers, and users that you’ve addressed these threats.
Susan Alpert, principal of SFA Consulting, explains the role of clinical evidence for combination products and the complexities at play.
What are the challenges faced by OCP?
What is the responsibility of the design owner? What level of accountability does the supplier have? What follow-up actions must a supplier take? A variety of best practices need to be driven forward by both suppliers and OEMs in an organized manner to ensure patient safety.
Critical subcontractors and crucial suppliers will be subject to unannounced audits by notified bodies under the revised European device regulations. Richard DeRisio of TÜV Süd provides more details in this presentation.