Don’t Let the EU MDR Transition Delay Fool You
A recent timeline shift for the European Union’s Medical Device Regulation (EU MDR) has created what one regulatory expert is calling, “The Great Misunderstanding of the MDR Amendment.”
A Combined Effort for Drug Delivery & Combo Product Technology
The annual Combination Products Summit focuses on solutions for the dynamic drug delivery/combination products industry with evolving regulations.
Don’t Fear the Audit: Benefits of Good Quality Practices
Quality is a loaded word. For the general public, it connotes excellence, value, worth—all of which we strive for in our business. But for some in the medical device industry, it’s about bureaucracy, liability, and conflict. Maintaining a quality management system (QMS) per the expectations of regulatory bodies can be time-consuming, confusing, expensive, and tedious.
Study Suggests Increased Number of PMA Supplements Increase Recall Risk
a study published in JAMA Network Open reported that high-risk medical devices whose manufacturers file supplements to the FDA so modifications can be made to PMA-approved products are 30% more likely to be the subject of any recall and high-risk Class I recall.
Beware of Defective Medical Device Packaging
An FDA safety communication issued Thursday serves as a reminder that medical device packaging plays a critical role in the lifecycle of the device itself.
CMS Delves into Expanding Access for Emerging Technologies
The agency said it would work in the coming months to explore policy options…….
5 Strategies for Managing Medical Product Supply Chain Uncertainty
Utilizing real-time data to deliver customers’ orders on time—while ensuring quality and maintaining margins……
Letting the Light In: How Failure Analysis is the Cornerstone of Success
Failure analysis is a vital part of the process of developing medical devices that function safely and efficiently……
Transforming Health Care:The Drive For Digital Health and Health IT
Rapid developments in healthcare technology, combined with improved data collection, pandemic pressures and increased consumer demand for tech-enabled and virtual health care, are fueling innovation and transformation in the digital health space……
5 Thoughts on Harmonization of Quality Regulation
FDA wants to align its quality system regulation with ISO 13485:2016. Global regulatory experts share their thoughts on what this harmonization could mean for regulatory bodies and the medical device industry……
