The center intends to facilitate partnerships, exchange knowledge and promote innovative regulatory approaches.
A Q&A with MedCrypt’s Axel Wirth sheds light on urgent problems that the medtech industry is facing regarding device security, but assures us that the sky is not falling.
Combining “fit, filtration and efficiency” is the key to enhancing protection and encouraging compliance.
Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.
Managing how a material can affect a device’s success starts with a strong, collaborative relationship with your materials supplier, which can help prevent a myriad of issues throughout the development of medical devices.
The IGNITE American Innovation Act aims to help small- and mid-sized businesses affected by the COVID-19 pandemic.
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.
The most successful medical device companies have the same characteristic in common: They’re cross-functional. Whether it be the device design and development activities or quality and regulatory affairs, every operation works together to produce and market medical devices that improve patients’ lives.
Innovation requires the space for failure and continuous improvement.
FDA, CDC and other agencies are trying to foster the development of diagnostics, therapeutics and vaccines that help address the outbreak.