Meet Yvette , one of LEC Subject Matter Expert

by | Jun 6, 2018 | Audits, CAPA, Communication, Compliance, Engineering, FDA Inspection, Guidelines, Human Error, Innovation, ISO, Logistics, Manufacturing, Medical Devices, Mitigation Strategies, Quality Systems, Recruiting, Regulatory, Risk Assessment, Training

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

by | Jun 6, 2018 | Communication, Community Service, Compliance, Engineering, Envision, Ethics, FDA, Guidelines, Laws, Leadership, Manufacturing, Medical Devices, Mitigation Strategies, Process Improvement, Professional Development, Technology

 FDA Issues Draft Guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Today, the U.S. Food and Drug Administration issued the draft guidance document, “Requests for Feedback and Meetings for Medical Device...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

by | Jun 6, 2018 | Commitment, Communication, Compliance, Engineering, Envision, Ethics, FDA, Guidelines, Innovation, Manufacturing, Medical Devices, Process Improvement, Recognition, Regulatory, Risk Assessment, Team Work, Technology

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

by | Jun 4, 2018 | Communication, Community Service, Compliance, Engineering, Envision, Ethics, FDA, Guidelines, Laws, Leadership, Manufacturing, Medical Devices, Mitigation Strategies, Process Improvement, Risk Assessment, Social Responsibility, Technology

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

by | May 31, 2018 | Communication, Compliance, Engineering, FDA, Guidelines, Laws, Manufacturing, Medical Devices, Mitigation Strategies, Pharma, Professional Development, Regulatory, Risk Assessment, Training

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...