Training

In-depth regulatory standards for medical devices (not software specific)

This training focusses on XXX and XXX, and will make sure that you will know all the basics of SDMD Regulatory Insights

Training

In-depth regulatory standards for medical devices (not software specific)

This training focusses on XXX and XXX, and will make sure that you will know all the basics of SDMD Regulatory Insights

The course at a glance

What you’ll learn:

For who?

UPCOMING TRAININGS

10-02-23

Software Development for Medical Devices

10-02-23

Cybersecurity according to the FDA guidance 2023

10-02-23

The IEC 62304 standard in-depth

10-02-23

Software development basics for regulatory professionals

10-02-23

Usability Engineering according to IEC 62366

+5 more

UPCOMING TRAININGS

10-02-23

Software Development for Medical Devices

10-02-23

Cybersecurity according to the FDA guidance 2023

10-02-23

The IEC 62304 standard in-depth

10-02-23

Software development basics for regulatory professionals

10-02-23

Usability Engineering according to IEC 62366

10-02-23

In-depth regulatory standards for medical devices
(not software specific)

Course Content

Course content

Part 1 - Regulatory overview

ISO 13485

ISO 13485 specifies requirements for a quality management system for medical device manufacturers to ensure consistent design, development, production, installation, and delivery of safe and effective products.

Part 1

Regulatory overview

Part 1

Regulatory overview

ISO 13485

ISO 13485 specifies requirements for a quality management system for medical device manufacturers to ensure consistent design, development, production, installation, and delivery of safe and effective products.

ISO 13485

IEC 62304 specifies the software life cycle processes for medical device software, including planning, design, implementation, testing, and maintenance, to ensure the safety and effectiveness of the software.

EU MDR

The EU MDR requires medical device software to meet specific regulatory requirements, including risk management and clinical evaluation, to ensure its safety and performance as an integral part of the medical device, focussing on EU regulations.

FDA CFR

The FDA CFR provides regulatory requirements for medical device software, including design controls, software validation, and risk management, to ensure its safety and effectiveness, with a focus on US regulations.

Part 2

Impact on your software development practices

Part 2

Impact on your software development practices

Testing Impact

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Design and then Develop

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Architecture

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Team impact

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Ready to upskill?

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TRUSTED BY

About our trainers

About our trainers

Other relevant trainings

We offer other workshops that gives a deepdive into the modules talked about in this general introduction course.

Software development basics for regulatory professionals

This workshop will provide a comprehensive understanding of the regulatory standards and requirements for medical devices, covering topics such as design control, risk management, quality system regulations, and post-market surveillance.

Usability Engineering according to IEC 62366

This workshop will provide a comprehensive understanding of the regulatory standards and requirements for medical devices, covering topics such as design control, risk management, quality system regulations, and post-market surveillance.

In-depth regulatory standards for medical devices

This workshop will provide a comprehensive understanding of the regulatory standards and requirements for medical devices, covering topics such as design control, risk management, quality system regulations, and post-market surveillance.