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 FDA Issues Draft Guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Today, the U.S. Food and Drug Administration issued the draft guidance document, “Requests for Feedback and Meetings for Medical Device...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

Welcome to our Team !!

 What is Lean Enterprise Consulting and how this team of SMEs can assist you ? Lean Enterprise Consulting Inc. (LEC) is a leading provider of business improvement solutions utilizing actual science-based management methodologies. Comprised of management interventions,...