The outlook for 2020 and beyond is positive, but medical device companies must continue to evolve their technologies and partnerships to keep the attention of investors.
Special controls are also provided for reasonable assurance of the safety and effectiveness of the devices impacted by the reclassification.
2020 should be a pivotal year in which the microcosm of medical devices moves out of the shadows and joins the mainstream healthcare conversation.
It’s time for medtech design engineers to take a page from the enterprise security playbook.
A look at IP litigation in 2019 and the year ahead, and some advice on how medical device companies can safeguard their intellectual property.
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.
The agency’s move is a win for early screening of a rare genetic disorder, which leads to progressive muscle deterioration.
The goal of the voluntary program is to streamline the submission process. The agency also announced that it has selected participants for its EtO Innovation Challenges.
The report also found that medical device companies are taking “huge gambles” in the area of risk management.