How MDSAP Can Help you Get out of Covid-19 era Faster Than Anyone
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;
- The goals of MDSAP
- International Regulators
- The history of the IMDRF
- The MDSAP Pilot program basics
- The MDSAP Audit Model
- The primary processes of MDSAP
- MDSAP and ISO 13485
- 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.
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)
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;
- Introduction to MDSAP
- The MDSAP Audit Model Overview
- Preparing for MDSAP Audit Process
- The MDSAP audit
- MDSAP Roles and Responsibilities During the Audit
- 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.
|INTRODUCTION TO MDSAP||Coming Soon|