Online MDSAP Training on the IMDRF's Medical Device Single Audit Program

Comply Guru are the first in the world to offer Multi-Accredited Online MDSAP Training in the United States with the Chartered Quality Institute (CQI), International Registrar of Certificated Auditors (IRCA), Exemplar Global and the Regulatory Affairs Professionals Society (RAPS) offering credentials for the Medical Device Industry that are globally recognized.

The IMDRF’s Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. It is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan, and the United States.

Comply Guru offer different types of MDSAP training courses depending on the target audience and training needs. We can also tailor training to meet your company’s specific needs or requirements. Our courses are available in multiple formats from eLearning, Blended Learning or Instructor-led Learning to help you or your organization master the IMDRF’s Medical Device Single Audit Program (MDSAP).

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4.7 ★★★★★ 86 Reviews

ISO 19011 MDSAP Medical Devices

MDSAP Auditor Training

20hrs

Price: $1195.00

MDSAP Auditor Training provides learners with the knowledge and skills required to understand and complete an audit against the IMDRF Medical Device Single Audit Program (MDSAP) for medical device quality management based on ISO 13485 and international regulatory bodies medical device regulations.

MDSAP Requirements for Practitioners and Auditors

4.5 ★★★★★ 145 Reviews

MDSAP Medical Devices

MDSAP Requirements Training

12hrs

Price: $795.00

MDSAP Requirements Training provides learners with the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) and the MDSAP audit approach.

ISO 13485 MDSAP FDA QMSR Medical Devices

Regulatory Reliant Internal Auditing for Medical Devices

20hrs

Regulatory Reliant Internal Auditing for Medical Devices is for existing Internal or Lead Auditors seeking the knowledge & skills to perform internal audits based on integrating ISO 13485, MDSAP and FDA QMSR requirements.

FDA Regulatory Requirements for Medical Devices (United States)

4 ★★★★★ 2 Reviews

MDSAP FDA QMSR FDA QSR 21 CFR 820 Medical Devices

U.S FDA Regulatory Requirements for Medical Devices

120mins

This course provides an overview of the United States FDA Regulatory Requirements for Medical Devices.

5 ★★★★★ 1 Reviews

MDSAP Medical Devices

Introduction to MDSAP

45mins

Introduction to MDSAP Training is for organizations looking for a concise, high-level introduction for their staff.

MDSAP Medical Devices

Japan PMDA/MHLW Medical Device Regulatory Requirements

120mins

This course provides an overview of Japan’s regulatory framework for medical devices under the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW).

MDSAP Medical Devices

Brazil ANVISA Medical Device Regulatory Requirements

120mins

This course provides an overview of the Brazilian regulatory framework for medical devices governed by ANVISA.

MDSAP Medical Devices

Australia TGA Medical Device Regulatory Requirements

120mins

This course provides an overview of the Australian regulatory framework for medical devices under the Therapeutic Goods Administration (TGA).

MDSAP Medical Devices

Health Canada Regulatory Requirements for Medical Devices

120mins

This course provides an overview of the Canadian Regulatory Framework for medical devices governed by Health Canada.

WHAT'S NEW

2026 Training Guide

Transformational Training for ISO Standards, Auditing & Medtech QA/RA

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Our team has you covered with expert insights & updates to stay on top of the latest updates, trends, and changes in the industry.

Design Controls, Design and Development under FDA QMSR

Michelle discusses Design Controls, ISO 13485 Design and Development and what endures under the FDA's QMSR in effect from February 2026....

Reaffirmed, Not Static: ISO 13485 and the Global Regulatory Evolution

Michelle discusses the recent affirmation of ISO 13485:2016 and shares her insights on the new guidance reflecting a Global Regulatory Evolution....

Low Risk Does Not Mean No Risk

Michelle discusses why ISO 13485 and ISO 14971 make a critical clarification on Risk, and clarifies a dangerous misconception in medical device develo...

CONFORMITY & COMPLIANCE LEARNING SOLUTIONS

Online MDSAP Training on the IMDRF's Medical Device Single Audit Program

2026 Training Guide

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