Regulatory excellence is now considered a pathway to innovation and sustained business growth, making it a fundamental component of success in the medical devices industry. MedTech manufacturers are fostering a culture of regulatory excellence to enhance compliance with regulatory requirements and ensure product safety, efficacy, and quality in the global marketplace.
Automation and digitization of quality processes can improve efficiency, reduce costs, and enhance product quality in manufacturing, allowing for more informed decisions that will contribute to long-term success.
The FDA is hosting it next town hall on medical device sterilization on April 29. The session will include discussion on topics and formats for future sessions in the series.
The consent decree restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the U.S. until certain requirements are met.
510(k) submissions have been a hot topic of late! Before you start your 510k submission make sure you’re aware of the pitfalls. Being responsible for writing and submitting a 510(k) can seem overwhelming – especially when tied to a scheduled product launch or marketing campaign driven by revenue goals. One of the most influential factors to a successful 510(k) submission is strategic planning.
In his new role, Kesavan will assume responsibility for leading CitiusTech’s global delivery organization. This will encompass enhancing practice capability, service delivery maturity, market innovation to drive profitable business growth by collaborating across practices, markets, delivery and functions.
The pilot program launched by Baxter International and Northwestern Medicine in Chicago resulted in the recycling of more than 170,000 IV bags. Baxter is now working to expand the program in the Chicago area to further validate the process and economic viability of the program.
Class 1 recalls are at a 15-year high. To reduce the number of recalls and nonconformances, medtech manufacturers need quality management and traceability processes that go beyond documenting and tracking changes to effectively connect people, processes and data.
As technology component pricing continues to rise, MedTech manufacturers are applying proven methods and exploring new approaches to maintain profitability and extend product lifecycles.
How innovators in the femtech space can protect their inventions and defend market share.
