Content by Alonso Diaz, Maria DiBari
Medical Device Recalls Outpace All IndustriesFDA guidance and corporate strategies can shape a company’s resiliency
Tue, 03/26/2024 - 12:03
The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls. FDA product recalls are on the rise in the post-pandemic era. There has been a clear upward trend from 2021 through 2023, and medical…
FDA Inspections on the RiseConsulting the FDA’s Case for Quality program
Wed, 01/31/2024 - 12:03
Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine. The rise has more…
The Price of ExcellenceUnderstanding the value of quality
Wed, 01/24/2024 - 12:01
Quality consistently ranks among organizations’ foremost competitive priorities; it’s a prerequisite for success in the global marketplace. Firms that want a competitive edge do it by delivering products that meet customer needs and function as…
Activating Creative Leadership and Collaborative TeamsTools for fostering synergy at your company
Tue, 05/23/2023 - 12:03
The pandemic has sparked a shift in many business models around the world, especially in the MedTech industry. The old manual labor model has sharply transitioned into businesses leaning on digitization and remote working models to cut costs,…
Using CAPA to Improve the Health of Your Business Build a CAPA-conscious work environment
Mon, 02/13/2023 - 12:02
A company’s quality management system should have a formal, effective, and efficient corrective action and preventive action (CAPA) program so management can stay informed and correct existing business problems. The data output and corrective…
Building a Framework for Machine-Learning Compliance in Regulated IndustriesThe need for transparency in a changing regulatory landscape
Wed, 05/18/2022 - 12:03
There’s been a big increase in artificial intelligence (AI) within digital health technologies. The cross between medical technology and AI requires that products be evaluated in accordance with domestic and international regulations. These…