MDSAP Series of Articles Overview

Rami.Azulay March 20th, 2020 Posted by Rami Azulay( ) Requirements Management Tool

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The purpose of this MDSAP series of articles is to examine the process of preparing and applying for the Medical Single Audit Program (MDSAP). The series is outlined in a way that benefits any medical device company that is planning to join or just joined the MDSAP program. Additional benefits include an overview of the program and links to more resources on certain topics.

The purpose of this series of articles  is to help medical device companies understand the following;

  • The Audit Process and History of the Program
  • The necessary company preparation that This for applying to MDSAP.

The learning objectives of this series of articles  are as follows;

  1.     The goals of MDSAP
  2.     International Regulators
  3.     The history of the IMDRF
  4.     The MDSAP Pilot program basics
  5.     The MDSAP Audit Model
  6.     The primary processes of MDSAP
  7.     MDSAP and ISO 13485
  8.     MDSAP Audit Structure

Who Should Read This Articles?

The MDSAP series of articles is for people in the Life Science industry that are responsible for quality assurance, quality control, or the implementation of a quality management system in accordance with ISO 13485 2016, and preparing for is an MDSAP audit. Below is a glossary of terms you are likely to encounter in this series of articles.

As well as global operation companies who may need to move some operations across sites under the same single audit program.

Glossary

ANVISA: Agencia Nacional de Vigilancia Sanitaria (Brazil)

AO: Auditing organization

CMDCAS: Canadian Medical Devices Conformity Assessment System

CRO: Contract Research Organization

DUNS: Data Universal Numbering System

EU: European Union

FDA: Food and Drugs Administration (USA)

GHTF: Global Harmonization Task Force on Medical Devices

IMDRF: International Medical Device Regulators Forum

IVD: In-Vitro Diagnostics

MAH: Marketing Authorization Holder (Japan)

MDAP: Medical Device Application Procedure

MDSAP: Medical Device Single Audit Program

MHLW/PMDA: Ministry of Health Labor and Welfare/ Pharmaceuticals and Medical Devices Agency (Japan)

NC: Non-Conformity

PMA: Pre-Market Approval

eQMS: Electronic Quality Management System

QSIT: FDA Quality System Inspection Technique

RAC: Regulatory Authority Council

SME: Subject Matter Experts

TGA: Therapeutic Goods Administration (Australia)

UDI:  Unique Device Identification

ALM: Application Life Cycle Management (SDLC) – Design Control

WHO: World Health Organization

Orcanos: Design Control and Quality Cloud Platform

 

Series of articles Modules

There are 6 modules in the MDSAP series of articles. They are;

  1. Introduction to MDSAP
  2. The MDSAP Audit Model Overview
  3. Preparing for MDSAP Audit Process 
  4. The MDSAP audit
  5. MDSAP Roles and Responsibilities During the Audit
  6. Benefits and Future of MDSAP

To get started, we will be going over modules 1 and 2.

Please stay tuned and follow our next articles on this series INTRODUCTION TO MDSAP.

Related Topics:

INTRODUCTION TO MDSAP Coming Soon

 

 

 

                                                                                                                  

 


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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