by Thomas Agrait | 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,...
by Thomas Agrait | 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FDA Issues Draft Guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Today, the U.S. Food and Drug Administration issued the draft guidance document, “Requests for Feedback and Meetings for Medical Device...
by Thomas Agrait | 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...
by Thomas Agrait | 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...
by Thomas Agrait | Jun 1, 2018 | Communication, Compliance, Engineering, FDA, Guidelines, Innovation, Laws, Medical Devices, Regulatory
FDA Announces Certain Class II Devices Exempt from Premarket Notification Requirements Today’s Federal Register announces the FDA’s exemption of a list of certain class II devices from premarket notification [510(k)] requirements. This finalizes the proposed list of...
by Thomas Agrait | 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...
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