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.
Mitigating risk of failure is one of the most important disciplines to perform for medical device manufacturers, and for the last couple of years, it has become an increasingly difficult discipline to master.
Inspecting for quality after a process is completed is reactive and outdated. Instead, the future lies in predicting quality and quality issues. For medical device manufacturers, the advantages in predictive quality are so great they simply cannot be ignored.
Data analytics can provide a more streamlined view of your customers and simplify the complex challenges faced by medical device commercial operations teams.
Innovative Publishing names new face for MedTech Intelligence