Mastering DHF, DMR, And DHR Course: Essential Documentation In Medical Device Manufacturing  (ONLINE EVENT: November 26, 2024/ON-DEMAND)
Mastering DHF, DMR, And DHR Course: Essential Documentation In Medical Device Manufacturing  (ONLINE EVENT: November 26, 2024/ON-DEMAND) . (MENAFN - GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Mastering DHF, DMR, and DHR: Essential Documentation in Medical Device Manufacturing Webcast" webinar has been added ...
América - MenaFN
(MENAFN- GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Mastering DHF, DMR, and DHR: Essential Documentation in Medical Device Webcast" webinar has been added to ResearchAndMarkets.com's offering.



Medical device manufacturing is not an easy process. If anything goes wrong, the entire batch of products is at stake. Is there any solution to it? DHF, DMR, and DHR are the three Ds of medical device that needs to be managed carefully.

Even though these files serve different purposes, it is essential to understand how they are mutually inclusive for effective technical documentation. This seminar offers a deeper insight into the documentation part of medical device manufacturing. Moreover, the seminar will cover the latest requirements proposed by FDA and European Union.

Let's dive deeper into the topics covered!

Course Overview

Breaking down each of these terms for a better understanding of freshers into medical device manufacturing.



Design History File (DHF): Includes an entire history of the device's design, which justifies the currently approved design.

Device Master Record (DMR): Associated with device production and highlights the requirements like material, equipment, and surroundings. Device History Record (DHR): Contains production-related documents which consist of dates, quantity, and labels of final products.

It is essential to have proper knowledge of technical documentation because these are submitted to the FDA. Additionally, these play an important role in pre-market approval of the device. It is crucial for regulatory compliance and this course focuses on future trends and the typical table of contents.

The core purpose of this seminar is to highlight the general safety and performance requirements. Moreover, the coach pays special attention to the file auditing process by FDA and notified the body to make the execution of the concept easier for professionals.

Who Should Attend:



Quality and Research Analyst: To verify regulatory compliance effectively and document everything as per the norms.

R&D Professionals: Incorporate device history and master records for innovative changes

Engineering: To understand the mechanism and design effectively

Production: To be able to create an estimate of the project and timeline of the manufacturing process Marketing: Knowing the in and out of a product will allow these professionals to execute marketing strategies effectively

Key Topics Covered:

Session 1



Introduction

Design Control Under 21 CFR 820.30

Design and Development Planning under ISO 13485:2016 7.3

The U.S. FDA's DHF

The EU MDR's D&DPF

MDR's "General Safety and Performance Requirements"

Device Classification - U.S. FDA vs. EU MDD

Design Files' "Typical" Contents The DMR and DHR / Lot / Batch Record TD Expected Contents

Session 2



Risk Management / File Under ISO 14971

Narrative

Hazzard Analysis

FTA

D-, P-, and U-FMECA's Report

Session 3



Human Factors / Use Engineering Under IEC 62366-1:2015

The User Interface

The 9 Stages The HF / UE File

Session 4



Putting It All Together

Design Control

The Team

Concurrent Compilation of the Three Files

Derivative Documents Development

Completion

FDA and NB Audit Focus Final Q & A

For more information about this webinar visit

About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

CONTACT: CONTACT: Laura Wood,Senior Press Manager ... For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Jordania
https://menafn.com/images/Menafn_SmallLogo.jpg
https://menafn.com/1108865039/Mastering-DHF-DMR-And-DHR-Course-Essential-Documentation-In-Medical-Device-Manufacturing-ONLINE-EVENT-November-26-2024ON-DEMAND
2024-11-08
rss
(MENAFN - GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Mastering DHF, DMR, and DHR: Essential Documentation in Medical Device Manufacturing Webcast" webinar has been added ...
Mastering DHF, DMR, And DHR Course: Essential Documentation In Medical Device Manufacturing  (ONLINE EVENT: November 26, 2024/ON-DEMAND)