Quality Considerations for Drug-Device Combination Products
Understanding the GMP requirements of each component is critical to product and compliance success.
Tag Archives: quality
Considering CAPA: Maybe It’s Not a Monster After All
It’s time to consider CAPAs as opportunities rather than just other issues to tackle.
Q3 Medical Device Recalls Fall Nearly 30%, but Still on Track to Exceed 2019
Top reasons for recalls include software, quality and parts issues.
The Top Trend for Medical Devices in 2021? Putting Quality First
Moving too quickly in the product development process can lead to mistakes.
Why Medical Device Makers Need to Revamp How Products are Manufactured
With digitalization impacting all areas of manufacturing operations, it should come as no surprise that medical device producers must adapt or risk missing the next wave of performance and product improvements.
Asia 2020 Device Regulatory Update
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
Asian Governments, Private Sector Response to Pandemic Shows Opportunity, Challenge
In general, the Asian markets have controlled the COVID-19 virus successfully outside of China, but its effect has still led to new developments and trends.
Playing by the Rules: A Lever for Doing Better Business?
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
Best Practices for Leading Medical Device Teams During the COVID-19 Pandemic
As COVID-19 sweeps the globe, it’s becoming increasingly difficult for medical device leaders to navigate the arising challenges and prepare for the future.
Allergan, Ideal Implant Hit with FDA Warning Letters for Breast Implants
The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
