2019 JALEX Medical Newsletter

Sharing the Spotlight

April 17-18, 2019 3rd Annual Medical Capital Innovation Competition

The M edical Capital Innovation Competition  was held at the Global Center for Health Innovation in Cleveland on April 17-18, 2019. The theme for the competition, “Virtual Reality and Cross Reality Technologies." The competition awarded a total of $100,000 plus mentoring and co-development opportunities to global startups in professional and collegiate divisions. There were 79 applicants, yet only 21 finalists. Congratulations to our Clients from Mediview XR for taking the second place spot! https://www.himssinnovationcenter.org/passion-heal-arvrxr-2019-mcic-winners (photography provided by the above link).

JALEX Medical Resource Center

UDI Class I and Unclassified Medical Device Deadline for Compliance September 24, 2020

Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45 . 2019 is an important year for our JALEX Clients with Class I Medical Devices that have not yet undergone the FDA UDI compliance process. As the September 24, 2020 deadline approaches, our team stands prepared to help execute and provide solutions to those with UDI projects. If you have a device that falls within this requirement, contact us today to see how we can help.

"My experience with JALEX has been phenomenal! The JALEX medical staff is at the top of my list as they are extremely knowledgeable and strategic.  I do not hesitate to recommend them as they have exceeded our expectations.” 2019 Medical Device Company

Conferences

If you are attending or exhibiting at the upcoming AOSSM Conference in Boston, then contact us today for an in-person meeting.

May 16th - Columbus, Ohio

May 9th - Cleveland, Ohio

Schedule an Appointment with JALEX Medical

Events

June 19, 2019 JALEX Medical attended the START UP SCALE UP event in Cleveland, Ohio. If you haven't ever attended, consider it for next year! The event is focused on showcasing the regions growing number of entrepreneurs and resources available.

Careers

Now Hiring Regulatory and Quality Systems Specialists If you have an interest in becoming part of a growing & innovative medical device development team, then send us your resume.

CAREERS@JALEXMEDICAL.COM

Device Design Biomedical design engineers to support you from concept through every stage of development.

Regulatory Affairs Guidance to assist you in meeting every standard and regulation to secure your pathway to success in the US or abroad.

Quality Systems Guidance to define your quality objectives and develop the deliverables to integrate quality into all facets of your project.

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