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IEC 62304 ED1 Training Medical Device Software Lifecycle Edition 1 · 2006+A1:2015
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Privacy & Data Protection

This page explains what personal information this site handles, where it goes, and what rights you have over it. It is written to be read, not to be skimmed past.

Last updated: 30 July 2026

The short version

  • This site sets no cookies, uses no analytics, and loads nothing from advertising or tracking companies.
  • The only information you actively give us is what you type into the contact form. It is used to reply to you and nothing else.
  • Contact form messages are handled by Formspree, a service based in the United States, which turns your message into an email to us.
  • Your quiz name and score are never sent anywhere. They stay in your browser and disappear when you close the tab.
  • We never sell or share your information for marketing.

Who is responsible for your information

The data controller — the party legally responsible for the personal information described here — is:

St John Lynch & Co Ltd
Email: niamh@stjohnlynch.com

If you have a question about your information, or you want to exercise any of the rights described further down, that address is the place to write.

The contact form

What we collect

Only what you type in: your name, your email address, optionally your role from the dropdown, and your message. There are no hidden fields collecting anything about you. The form does contain two hidden fields, and it is worth being open about what they are: one sets the subject line of the email we receive, and the other is an empty anti-spam field that automated bots fill in and humans never see.

Why we need it

To read your message and reply to it. Your email address is needed because there is no other way to answer you. Your name is needed to address you properly. That is the entire purpose — your details are not added to a mailing list, and you will not receive anything you did not ask for.

Our legal basis

We rely on legitimate interests under Article 6(1)(f) of the UK and EU GDPR: you have chosen to contact us, and we cannot respond without processing what you sent. If you would rather we did not hold your message at all, say so in your message or write to the address above and we will delete it.

Who else sees it

When you press Send, your message is transmitted to Formspree, a form-handling service, which converts it into an email and delivers it to us. Formspree therefore processes your message on our behalf. Their own privacy policy is published on formspree.io.

This involves a transfer outside the European Economic Area. Formspree is based in the United States, so your name, email address and message are sent to and stored on servers there. We consider this proportionate for a simple contact form, but you are entitled to know it happens before you decide to write to us. If you would prefer your information not to leave the EEA, email us directly at the address above instead of using the form.

Nobody else receives your message. It is not sold, rented, shared for marketing, or used to build a profile of you.

How long we keep it

We delete your message once your query has been dealt with, and in every case no later than 48 hours after we have replied. In practice that means removing both the submission held by Formspree and the email in our inbox. We do not keep contact form messages as a long-term record, and we do not archive them anywhere else.

Information stored in your browser

This site stores small pieces of information on your own device, using a browser feature called local storage. It survives closing the tab and the browser, until you clear it yourself — deliberately, for the progress-tracking items below: they are shared across every tab you have this site open in, which a shorter-lived alternative is not, and losing your progress the moment you closed a tab is not something a course progress tracker should do.

What is storedWhy
62304_trainingLevel Remembers whether you chose Introductory or Advanced, so you do not have to reselect it on every page
62304_bannerDismissed Remembers that you closed the notice about IEC 62304 Edition 2, so it does not keep reappearing
62304_theme Remembers whether you chose the light or dark theme. Only written once you use the toggle — until then the site simply follows your device's own light/dark setting and stores nothing
62304_studiedPhases Remembers which Learn topics you have marked studied, so the progress bar and each card's status stay correct — across every tab you use, and across visits
62304_previewedDocs Remembers which example documents you have previewed or downloaded — a topic can only be marked studied after this

None of the five items above identifies you. All stay on your device, are never transmitted to us or anyone else, and can be cleared at any time through your browser's "clear browsing data" settings. Because they exist purely to make the site work as you have asked it to, no consent banner is required for any of them.

This site sets no cookies at all.

The quiz and your certificate

This is worth stating plainly, because it is the part people most often assume works the other way: the name you type before the quiz, your answers, and your score are never sent anywhere. They exist only in your browser's memory while the tab is open, are used to fill in the certificate you print yourself, and are gone the moment you close or reload the page.

We do not know who has taken the quiz, what anyone scored, or how many certificates have been produced. There is no account, no login, and no record kept.

Hosting and server logs

This site is hosted on GitHub Pages. Like any web server, GitHub's servers record technical details of requests, which can include your IP address and which browser you are using. This happens automatically for every website you visit and is necessary to deliver pages to you. We have no access to those logs and cannot look you up in them. GitHub processes them under its own privacy statement.

What this site does not do

  • No cookies
  • No analytics or visitor statistics — we genuinely do not know how many people use this site
  • No advertising, tracking pixels, or third-party scripts of any kind
  • No external fonts or content delivery networks; every file the page loads comes from this site
  • No selling, renting, or sharing of personal information
  • No automated decision-making or profiling

Your rights

Under data protection law you have the right to:

  • Access — ask for a copy of the personal information we hold about you
  • Rectification — have inaccurate information corrected
  • Erasure — ask us to delete your information
  • Restriction — ask us to limit how we use it
  • Object — object to our processing where we rely on legitimate interests
  • Portability — receive your information in a transferable format

To exercise any of these, email niamh@stjohnlynch.com. We will respond within one month. In practice, the only information we are likely to hold is a contact form message you have sent us.

If you are unhappy with how we have handled your information, you can complain to the Irish supervisory authority, the Data Protection Commission (dataprotection.ie).

Changes to this notice

If what this site does with personal information changes, this page will be updated and the date at the top will change with it.

Where this site's content comes from

Accuracy matters more here than on most training sites, because someone may carry a conclusion from this course into a real regulatory submission. So it is worth being explicit about what came from where.

  • The course content is written by St John Lynch & Co Ltd, based on a licensed copy of IEC 62304:2006+AMD1:2015. The text of the standard is not reproduced here — requirements are paraphrased, and clause numbers are cited so you can look them up in your own copy.
  • The safety class mapping (which requirements apply to Class A, B or C) is taken from Table A.1 as amended and cross-checked line by line against the [Class …] tags in the normative text. The mapping carries the date it was last checked, and records the single entry that rests on inference rather than an explicit tag, so you can see exactly how solid each value is.
  • The Edition 2 status information comes from the publicly available IEC TC 62 work programme and TC 62 committee drafts. It is shown with the date it was last reviewed, because a standard under development moves and an undated claim about it quietly becomes wrong.

This site is not affiliated with, authorised by, or endorsed by the IEC. "IEC" and the standard designations referred to here belong to the International Electrotechnical Commission. Where this site and the standard disagree, the standard governs — check your own copy, and check the IEC website for the current development status before relying on anything said here about Edition 2.

One point that is a data protection matter: your browser never contacts the IEC, or any other third party, when you use this site. Everything the page loads comes from this site. Where information about the standard's development status is drawn from IEC, that happens away from your visit and is published here as an ordinary file, so no request of yours and no IP address of yours reaches IEC.

About this site

This is an educational training resource covering IEC 62304. It is provided for learning purposes and is not a certified or accredited qualification. Nothing on this site is legal or regulatory advice.

IEC 62304 Training — Based on IEC 62304:2006+AMD1:2015 (ED1)

Developed by St John Lynch & Co Ltd · Privacy & Data Protection