LEC PRAESENTI – To be Successful , change your Filters !

You want to achieve more in your Personal and Professional Life? Change your Filters, change your Perspective.  Too often, we think of “success” as an end when in reality It’s some destination that we have to reach. What so many people fail to...

Meet Yvette , one of LEC Subject Matter Expert

Meet Yvette @ Lean Enterprise Consulting Inc. Professional Summary: Dedicated professional, eager to provide services in general Quality Systems, using knowledge acquired during 25 years of service to regulated environments: Pharmaceuticals, Medical Devices,...

LEC PRAESENTI – FDA medical device or device-led combination product submissions

 FDA Issues Draft Guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Today, the U.S. Food and Drug Administration issued the draft guidance document, “Requests for Feedback and Meetings for Medical Device...
LEC PRAESENTI – Medtronic Recalled HeartWare HVAD

LEC PRAESENTI – Medtronic Recalled HeartWare HVAD

Showing a great level of Social and Business Responsibility, Medtronic HeartWare HVAD System Recalled Due to Unintended Intermittent Electrical Disconnection between The Power Source and The Controller The FDA has identified this as a Class I recall, the most serious...
LEC PRAESENTI

LEC PRAESENTI

The U.S. Food and Drug Administration (FDA) issued two guidances today related to shared system risk evaluation and mitigation strategies (REMS). A REMS is a required risk management plan that uses tools beyond the approved labeling (prescribing information) to manage...