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 – OSCOR Introducers and steerable guide sheaths

Please join our client, OSCOR,  at the 2nd Intervention Congress of the DGA in Hamburg and learn about their new introducers and steerable guide sheaths – “The Destino Twist and Destino Reach”. The Destino Twist and Destino Reach are the ideal...
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...