There are more and more mobile health apps created every day. Mobile medical devices and health apps must follow federal laws that apply to their product. The FTC has worked with the FDA, ONC, and OCR to release an interactive tool which will help mobile app developers understand which federal laws apply to their products. The user is able to … Read More
The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices final guidance has been released. The FDA posted a regulation down-classifying Medical Device Data Systems (MDDS) from Class III to Class I on February 15, 2011. Class I devices are subject to general controls under the FD&C Act. A draft guidance regarding MDDS was issued on … Read More
OMEDtech has recently launched it’s first video on our YouTube channel. This video gives a brief overview of how OMEDtech meets the needs of the medical device community. Please take a moment to check out OMEDtech’s first video and subscribe to our channel so that you don’t miss any of our upcoming video presentations.
The FDA Medical Device Industry Coalition is presenting a public workshop this Friday, April 11, 2014 in Dallas, Texas. OMEDtech is a member of FMDIC and will be representing OKBio at this workshop. This workshop, “Medical Devices – the Case for Quality,” will gather input from those in the medical device industry about how to improve quality practices. Click here … Read More
OMEDtech has been accepted into BSI’s Associate Consultant Program. While BSI does not endorse the services of ACP members it does “prescreen and approve members that have demonstrable experience with respect to specific management systems standard(s) where they have the competence to deliver consultancy services.” We are excited to have the opportunity to participate in this program.
OMEDtech attended the MedVentures Conference in Dallas, on October 10, 2012. MedVentures is an early-stage investment and education conference focusing on the rapidly growing medical technology sector. The medical technology sector includes medical devices and instruments, diagnostic equipment, medical therapeutic devices, medical monitoring equipment and other health-related products and services.
OMEDtech exhibited at the MDM Texas Exposition and Showcase in Fort Worth on March 14 & 15. OMEDtech and Tietronix shared a booth showcasing QMS development and management.
In 2002 David Makanani and Steve Ford, saw an opportunity to use their over 60+ years of combined experience in medical device development, to help companies successfully create products, move swiftly and accurately through the regulatory process and achieve market introduction in the shortest amount of time. OMEDtech was founded in that year to provide a resource with a proven … Read More