How to Prepare a Medical Device 510k Submission for FDA | Rob Packard | Joe Hage

Автор: MedicalMarcom

Загружено: 2018-10-26

Просмотров: 32984

Описание:

https://MedicalDevicesGroup.net/Webin... for the slides.

The Medical Devices Group presents Medical Device Academy founder Robert Packard. In an hour-and-a-half workshop, Rob covered Changes to RTA process, Human Factors Guidance, Changes to eCopy process, Small Business Qualification Changes, Interoperability Guidance, eSubmitter software status, Device Modification Guidances, Quik 510(k) Pilot, Impact of De Novo & Fee Changes, Cybersecurity Policies, UDI Requirements, New ISO 10993-1:2018 Standard.

How to Prepare a Medical Device 510k Submission for FDA | Rob Packard | Joe Hage

Доступные форматы для скачивания:

Скачать видео mp4

Информация по загрузке:

Скачать аудио mp3

Похожие видео

Mastering your 510(k) submission process

Mastering your 510(k) submission process

Navigator from Reed Tech | A Much Easier Way to Access and Use FDA Databases

Navigator from Reed Tech | A Much Easier Way to Access and Use FDA Databases

FDA Recalls: Fewer But How Many Near Misses? | Joseph Anderson IpX

FDA Recalls: Fewer But How Many Near Misses? | Joseph Anderson IpX

Documentation Deconstructed: Understanding the Technical file

Documentation Deconstructed: Understanding the Technical file

510k Workshop: How to Prepare an FDA Submission (Part I)

510k Workshop: How to Prepare an FDA Submission (Part I)

4 Hours Chopin for Studying, Concentration & Relaxation

4 Hours Chopin for Studying, Concentration & Relaxation

FDA Process for Medical Device Startups: an Investor's Point of View

FDA Process for Medical Device Startups: an Investor's Point of View

510(k) Project Management - Updated for 2021

510(k) Project Management - Updated for 2021

5 операций, которые я, как врач, НИКОГДА бы не сделал! / Вы ПОЖАЛЕЕТЕ об ЭТИХ операциях!

5 операций, которые я, как врач, НИКОГДА бы не сделал! / Вы ПОЖАЛЕЕТЕ об ЭТИХ операциях!

Травматолог №1: Суставы в 40, будут как в 20! Главное внедрите эти простые привычки

Травматолог №1: Суставы в 40, будут как в 20! Главное внедрите эти простые привычки

Net Zero Healthcare with Michelle Sullivan (Boston Scientific) | 10x London 2022

Net Zero Healthcare with Michelle Sullivan (Boston Scientific) | 10x London 2022

MDR regulation (EU) update from Bassil Akra

MDR regulation (EU) update from Bassil Akra

7 Steps to Respond to an FDA 483 Inspection Observation

7 Steps to Respond to an FDA 483 Inspection Observation

Proove Biosciences Redeemed: Back and Better Than Ever with Brian Meshkin at 10x Device Conference

Proove Biosciences Redeemed: Back and Better Than Ever with Brian Meshkin at 10x Device Conference

Design Controls - Requirements for Medical Device Developers

Design Controls - Requirements for Medical Device Developers

Software Validation Documentation for FDA 510(k) pre-market notification submission

Software Validation Documentation for FDA 510(k) pre-market notification submission

FDA 101 for Medical Devices

FDA 101 for Medical Devices

How to prepare a 510k submission for FDA

How to prepare a 510k submission for FDA

How to you create a Design History File (DHF)?

How to you create a Design History File (DHF)?

Как вылечить БЕЗ операций Близорукость,Дальнозоркость,Астигматизм,Косоглазие.Упражнения проф.Жданова

Как вылечить БЕЗ операций Близорукость,Дальнозоркость,Астигматизм,Косоглазие.Упражнения проф.Жданова