MDSAP: What It Is and How to Successfully Prepare for an MDSAP Audit

MDSAP: What It Is and How to Successfully Prepare for an MDSAP Audit

This course provides an overview of the MDSAP (Medical Device Single Audit Program), which allows a single audit of a Quality Management System to verify compliance with regulatory requirements from participating authorities [...]

Date

18 June, 2026

Registration Deadline

11 June, 2026

Format

Live Streaming

Language

Italian

Price

€580 for non-clients
€435 for clients — VAT excluded

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This course provides an overview of the MDSAP (Medical Device Single Audit Program), which allows a single audit of a Quality Management System to verify compliance with regulatory requirements from participating authorities. It also covers the program structure, audit approach, and key requirements to support effective audit preparation.

Key Points

ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes
TG(MD)R Sch3 – Australian Therapeutic Goods (Medical Devices) Regulations
RDC ANVISA 665/2022 – Brazilian Good Manufacturing Practices
SOR 98/282 – Canadian Medical Devices Regulations
MHLW Ministerial Ordinance No. 169 – Japanese Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents
QMSR 21 CFR Part 820 – Quality Management System Regulation
MDSAP AU P0002.10 MDSAP Audit Approach

Structure

8-hour course. (9.30 AM – 17.30 PM)
Certificate of partecipation

The course will be confirmed when reaching a minimum number of participants.

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