Essentials — MD Regulatory Academy

MD Regulatory Academy

Essentials: short courses on a single process

One regulatory or quality process per course: what the regulation requires, and how to document it on the template included.

Under an hour Template included Self-paced Access does not expire Certificate on completion

Approach

What an Essentials course covers

Full-length courses cover a whole area of the regulation. An Essentials course covers one process and nothing else.

01

Scope

The requirements that apply to the process, each with its article, annex or clause. The examples shown are extracts of the template.

02

Format

Under one hour of video, a test after each lesson, a final test and a certificate. The template is included in the purchase.

Questions

Common questions

How is an Essentials course different from a full course?

A full course covers a whole area of the regulation in depth, over several hours. An Essentials course covers one process in under an hour, and includes the template it is built on.

Is the template included?

Yes. The download link arrives with the order confirmation and stays available under My Account, Downloads.

How long do I have access?

Access does not expire, and lessons updated after your purchase are available to you at no additional cost.

What does the certificate confirm?

That you completed the course and passed the final test. It carries a verification code that anyone can check on a public page.

Can my company buy several seats?

Yes. Get in touch and we will arrange it, including a single invoice.

MD Regulatory Academy

Expert regulatory consulting and audit-ready documentation for medical device manufacturers — ISO 13485, EU MDR, FDA QMSR, MDSAP.

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