FDA’s five-point plan outlines the Agency’s thoughts on a tailored regulatory framework, good machine learning practices, patient approaches, technology biases and real world performance.
This month’s recap informs you of companies entering orthopedics with their first product clearance. The six companies we chose to highlight received their clearance within the last quarter of 2020.
Startups are boiling innovation engines that serve an essential role in the future of the orthopedic industry. While small companies are often laser-focused on technology, they must advance strategically to be successful.
Remote auditing will now be conducted on a case-by-case basis. Notified Bodies and members of industry expect the shift could ease the backlog created by MDR and COVID.
While COVID-19 has created much uncertainty for the industry's forecast, market fundamentals remain strong. We’re planning for modest growth in 2021 before the market begins to level off in 2022.
The future of orthopedic medical devices is small. To capitalize on this paradigm shift, now is the time to learn how to incorporate MEMS into your next big design idea.