MDSAP(Medical Device Single Audit Program) Introduction| What is an MDSAP|MDSAP Certification|

Подробнее о видео

MDSAP(Medical Device Single Audit Program) Introduction| What is an MDSAP|MDSAP Certification| @ivdmanufacturing7208

The International Medical Device Regulators Forum (IMDRF)External Link Disclaimer recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

International partners that are participating in the MDSAP include:

MDSAP Members
Therapeutic Goods Administration of Australia
Brazil’s Agência Nacional de Vigilância Sanitária
Health Canada
Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
U.S. Food and Drug Administration

MDSAP Official Observers:
European Union (EU)
United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA)
The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme

MDSAP Affiliate Members:
Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT)
Ministry of Health of Israel (NEW)
Republic of Korea's Ministry of Food and Drug Safety
Singapore's Health Sciences Authority (HSA)

List of Queries-
How To Implement MDSAP ( Medical Device Single Audit Program)?
Introduction to the Medical Device Single Audit Program MDSAP
What Is MDSAP (Medical Device Single Audit Program)? - Medical Devices QMS
Medical Device Single Audit Program: Overview
MDSAP Medical Device Single Audit Program
How to prepare your MDSAP certification? (Medical Devices)
How to get MDSAP Certified for your Medical Devices?
What is MDSAP And Why is it required?
Are you MDSAP? - The Medical Device Single Audit Program for Medical Device Industry
MDSAP Certification: Success and Failures
MDSAP Country Market Intro Blog Series
MDSAP Introduction
Medical Device Single Audit Program: Mission and Status

#ISO9001
#MDR2017
#production
#diagnostics
#Audit
#medicaldevice
#QMS
#IVDMANUFACTURING
#adsivdmanufacturing
#manufacturingindustries

✨ Subscribe and hit the bell icon to see the latest videos....

Follow Amar on your favorite Social Media Channels:

👉🏻 Facebook:

👉🏻 Instagram:

👉🏻

👉🏻 YouTube:

LETS LEARN TOGETHER AND GROW TOGETHER !!!!!!