Holmes appears to be headed for prison after an appeals court rejected her bid to remain free while she tries to overturn her conviction in a blood-testing hoax that brought her fleeting fame and fortune.
On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. “Unfortunately, the Agency finds that you are not fit for continued employment because your ability, knowledge and skills do not fit the Agency’s current needs, and your performance has not been adequate to justify further employment at the Agency,” said the letters.
In the healthcare industry where patient lives are at stake, quality culture is a cornerstone principle extending beyond operational efficiency. It has profound effects on patient outcomes. As tech continues to disrupt healthcare, how do technology companies build a robust quality culture to succeed in healthcare?
Computerized Maintenance Management System (CMMS) software can be a vital tool for life sciences manufacturers in maintaining compliance with regulatory requirements.
Overcoming 21 CFR compliance challenges – stringent equipment maintenance requirements, overwhelming documentation demands, the need to maintain data integrity. Insights into challenges healthcare organizations face with compliance and how to incorporate new tools and processes for streamlining maintenance processes, reducing compliance burdens, and ensuring the highest standards of safety and efficiency.
EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased workload, combined with the scarcity of expert resources, makes it essential to find innovative solutions that maintain efficiency and prevent burnout among highly skilled teams. How does use of technology help?
With numerous planned submissions underway for 2024, the new platform is setting a new standard for managing simultaneous submissions to multiple national regulatory authorities, paving the way for a much anticipated fully digital, single global dossier.
Medical device companies are aiming to optimize their Clinical Evaluation Report (CER) submissions and streamline compliance process. How are RA teams putting together practical strategies for improving efficiency, reducing risk, and staying compliant with MDR regulations?
An April 2024 survey of medical device regulatory professionals illustrates potential regulatory fatigue. See how resource constraints, ever changing global policy, and an underutilization of technology/digital process are impacting internal burden and fatigue and where implementing new regulatory strategies, upgrading organizational expertise, adding outsourced regulatory services are helping teams cope.
If you’re considering a RIM system, it’s critical to determine the right scope, software capabilities, and balance between cost and value. Learn how to evaluate each piece with this RIM buyer’s guide for medtech.
