Children’s reaction to Cochlear implant

OMEDtechNews & EventsLeave a Comment

When you’re frustrated with the regulatory process of getting a new medical device to market.  This article is a great reminder of why it’s worth the effort.  Watch what happens when children, who have received a cochlear implant, react to hearing for the first time.

Early registration ends June 1!

OMEDtechNews & EventsLeave a Comment

Early registration ends June 1 FMDIC’s early registration for the upcoming educational forum with FDA ends June 1. Registration fees go up thereafter. Registration info: http://fmdic.org/events-training/mdr-complaints-recalls/

FMDIC Public Workshop – June 15

OMEDtechNews & EventsLeave a Comment

Medical Device Reporting, Complaints, and Recalls, Corrections, and Removals Presented by the FDA Medical Device Industry Coalition Are you troubled by what you see in the news? Have you struggled with how to handle complaints from your users while maintaining Regulatory Compliance?  Do you often wonder about what is reportable to the FDA? Do you feel prepared if you had … Read More

Notified Body Audits Are Changing

OMEDtechNews & EventsLeave a Comment

News from the Medical Device Notified Body Meeting in Brussels:   Notified Bodies are being advised to use their existing authority to conduct more unannounced inspection visits to manufacturers, conduct product sampling, witness device testing during audits, and perform market surveillance. Guidance is expected to be developed and issued to Notified Bodies on these practices soon.

FDA ISO 13485 Voluntary Audit Report Submission

OMEDtechNews & EventsLeave a Comment

FDA CDRH is kicking off their ISO 13485:2003 Voluntary Audit Report Submission Pilot Program June 5, 2012.  FDA wants to explore how they can leverage off of some of the ISO 13485 audits being conducted by ISO conformity assessment bodies. The premise of the 13485 Voluntary Audit Report Submission Program was based on an amendment to the law, which is … Read More

MDM Showcase

OMEDtechNews & EventsLeave a Comment

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.

Welcome to Our New Website

OMEDtechNews & EventsLeave a Comment

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