Search

Products meeting the search criteria

Preparing a FDA 510(k) submission - What to Know in 2024

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 : This Event is Over and the Recorded Content is Available

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 60 Mins

Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments

Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments

10 Minutes excerpt from the recorded event for your review: Read the LinkedIn Article: Lin..

Date : 28th June 2024

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

10 Minutes excerpt from the recorded event for your review:Read the LinkedIn Article: LinkedIn ..

Date : 30th May 2024

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR-

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR-

Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and pr..

Date : 21st March 2024

Time : This Event is Over

Duration : 90 Mins

Risk Management for ML medical devices following BS/AAMI 34971:2023 and ISO 14971

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

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and..

Date : 29th January 2024

Time : This Event is Over

Duration : 90 Mins

RISK MANAGEMENT FOR ML MEDICAL DEVICES FOLLOWING BS/AAMI  34971 AND ISO 14971

RISK MANAGEMENT FOR ML MEDICAL DEVICES FOLLOWING BS/AAMI 34971 AND ISO 14971

Overview:In the field of medical technology, the integration of Machine Learning (ML) within medic..

Date : 28th August 2023

Time : This Event is Over and the Recorded Content is Available

Duration : 75 Mins

510K Submission Process for Medical Devices

510K Submission Process for Medical Devices

Overview: There are three types of 510(k) submissions that can be submitted – Traditional, Spec..

Date : 25th August 2023

Time : This Event is Over and the Recorded Content is Available

Duration : 75 Mins

510K Submission Process for Medical Devices

510K Submission Process for Medical Devices

Level:- Beginner to Intermediate Overview: There are three types of 510(k) submissions t..

Date : 21st November 2022

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

Sterilization of Pharmaceutical Products and Medical Devices

Sterilization of Pharmaceutical Products and Medical Devices

Overview: This topic will discuss the methods of sterilization to be used on medical devices a..

Date : 19th August 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 60 Mins

Risk Management for Medical Devices per ISO 14971:2019

Risk Management for Medical Devices per ISO 14971:2019

Overview: Risk management overarches projects associated with a particular product family, gi..

Date : 11th August 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 1 Hour 19 Mins

Showing 1 to 11 of 11 (1 Pages)