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Effective Technical Writing for Medical Devices: Improving Your Skills for Clear and Concise Communication
Overview: In the world of medical device manufacturing, technical writing is more than just a..
Date : 27th March 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
US FDA Requirements for Medical Products Labeling / UDI
Overview: The world of medical product labeling in the United States is governed by a complex ..
Date : 10th February 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Preparing a FDA 510(k) submission - What to Know in 2024
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 29th October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Overview: Test Method Validation (TMV) is a critical yet often misunderstood requirement in t..
Date : 21st October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
An Advanced Course on Lean Documents, Lean Configuration, and Document Control in 2024
Overview: In today's fast-paced life sciences industry, many companies struggle with cumberso..
Date : 20th August 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024
Overview: In the world of medical device development, the US FDA places a high priority on ri..
Date : 14th August 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Overview: 21 CFR Part 820 delineates the Quality System Regulation (QSR) that governs all ent..
Date : 23rd July 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304
Overview: In the fast-evolving field of medical technology, ensuring the safety and efficacy ..
Date : 28th May 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Risk Management for ML medical devices following BS/AAMI 34971:2023 and ISO 14971
Overview: FDA has always prioritized the risk management of medical devices, adhering to its ..
Date : 27th February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Sampling Plans for Verification and Validation, Production Process Validation and Production Control
Overview: When design flaws go unnoticed until late in production—or when a batch fails inspe..
Date : 23rd May 2025
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins