Integrating the well-respected and trusted Agilis brand and team extends Kymanox’s capabilities in human factors (HF) by adding incredible talent, the ability to conduct HF studies globally, and unparalleled regulatory strategy and support.
Read MoreOn December 9th the FDA released a new draft Guidance, Content of Human Factors Information in Medical Device Marketing Submissions. The new guidance takes a risk-based approach to determining the required amount of HF Data for a submission. In some instances, this will reduce the amount of HF Data required for modified devices.
Read MoreSkin cancer is the most common of all cancer types. More than 5 million skin cancers are diagnosed each year in the United States. That’s more than all other cancers combined. Skin cancer rates have been on the rise over the past few decades. The good news is that you can do a lot to protect yourself and your family from skin cancer.
Read MoreEvery year countries around the world celebrate World Blood Donor Day (WBDD). The event serves to raise awareness of the need for safe blood and blood products and to thank voluntary, unpaid blood donors for their life-saving gifts of blood.
Read MoreWhen was the last time you checked in on yourself? This Mental Health Awareness Month, find resources and information on ways to improve your quality of life.
Read MoreIs Risk management a check box for your design process or is a value added tool? Shannon Hoste joined Jon Speer and Etienne Nichols in their latest episode of the Global Medical Device Podcast.
Read MoreInternational Women's Day (March 8) is a global day celebrating the social, economic, cultural, and political achievements of women. The day also marks a call to action for accelerating women's equality.
Read MoreA panel of experts from ECRI, FDA, and the healthcare delivery community discussed the increasing concerns about cybersecurity risks in healthcare and actionable recommendations on how to reduce risks and meet challenges.
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