GSPR Checklist under the EU MDR — How to Complete It
€99.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
EU MDR 2017/745 · Annex I · Annex II, Section 4
GSPR Checklist under the EU MDR: How to Complete It
A completed GSPR checklist for your device: every requirement of Annex I decided, cited and evidenced, on the Excel template included with the course.
€99
VAT calculated at checkout
4 lessons · 40 min · Excel template
· certificate
Access does not expire
A checklist is not a list of standards
Annex II, Section 4 asks for four things on every requirement of Annex I: whether it applies and, if not, why; the method used to show conformity; the standard, common specification or other solution applied; and the precise identity of the document that proves it, with its place in the technical documentation.
A table can tick every row and still answer none of them. “N.A.” is not an explanation. “ISO 10993” is not a reference. “See risk file” is not the identity of a controlled document.
This course works through the template column by column and shows the form each entry takes, so that every row can be checked against the device and against the evidence.
- 4 lessons
- 40 min of video
- Excel template included
- Self-paced
- Certificate on completion
- Access does not expire
Scope
What the course covers
Article 5(2), Articles 8 and 9, Annex I and Annex II, Section 4 of the MDR, applied to the GSPR checklist row by row. Every extract shown in the lessons comes from the template you receive.
01
Applicability
Where Annex I states the condition that makes a section apply, in its opening words or in the section heading, and how to write a reason for “No” that anyone can check.
02
Standards and evidence
Harmonised or not, which edition, what Annex ZA covers, common specifications, other solutions, and the four elements of a precise evidence entry.
03
A complete table
The four statuses, the difference between partial applicability and partial status, the link to the risk management file, and six closing checks.
Outline
4 lessons, in the order the table is filled
Audience
Who the course is for
- Regulatory affairs specialists preparing technical documentation under the MDR
- Quality engineers asked to own the GSPR checklist
- PRRC who sign off the technical documentation
- Consultants and start-up teams building a first technical file
It assumes you know what a technical file is and have access to your device’s documentation. It does not assume prior work on a GSPR checklist.
What is included
What you get when you buy
- 4 video lessons, 40 minutes in total
- The GSPR Checklist Excel template, the one used in every lesson
- A test at the end of each lesson, and a final test
- A certificate with a verifiable code
- Every future revision of the course, at no further cost
The certificate
On passing the final test the certificate carries a code derived from your name and the date of completion. An employer, an auditor or a client can confirm it on a public page, and it can be filed as training evidence under ISO 13485 §6.2.
MDR-XXXX-XXXX · mdregulatory.com/verify
Questions
Before you buy
Is the template included?
Yes. The Excel template is part of the purchase: the download link arrives with the order confirmation and stays available under My Account → Downloads.
Do I need a copy of the MDR?
No. The regulation is free on EUR-Lex, and every requirement shown on the slides is quoted from it with its article or section reference.
Do I need copies of the harmonised standards?
Not for the course. You will need the standards you apply to fill your own checklist, and the course shows how to check their edition and what their Annex ZA covers.
Does the course cover the IVDR?
No. It is built on Annex I and Annex II of the MDR. The method transfers to the IVDR, but the sections and their conditions are different.
Is the course live, or can I start whenever I want?
It is self-paced. You start when you buy it and work through it at your own speed, from any device. There are no scheduled sessions.
How long do I have access?
Access does not expire. The course is tied to your account, 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, and it can be filed as training evidence under your quality management system.
What happens if I do not pass a test?
You can take it again. The rules for each test are shown on screen before you start it.
Can my company buy several seats?
Yes. Get in touch and we will arrange it, including a single invoice and the details your finance team needs.
GSPR Checklist under the EU MDR
4 lessons, 40 minutes of video, the Excel template and a certificate.
Self-paced, with no expiry.
€99.00
