Everything that helps you prepare for your next audit, kept in one place
Joining is free of charge. Members get a regulatory calendar that updates itself, a countdown to their next audit with email reminders along the way, a personal library of everything they downloaded, and a place to keep the results of the tools.
quality is a team sport.
Sharon Resnick, founder of qualityworks.
Members can also choose to receive the newsletter every two weeks.
What is waiting in your personal area
The dates of the markets you chose go into Outlook or Google and update themselves whenever a new date is added. Everyone can see the dates on the site; adding them to your own calendar is for members.
Enter the date of your next audit, and you get a countdown and email reminders as it gets closer, so the preparation starts on time.
The checklists, templates and gifts you downloaded are kept in one place, and you no longer need to type your email for every download.
For every tool result you get the full explanation: the rules that led to it, the references to the source documents and the next steps. Results are saved, and you can print each one as a PDF report.
The recordings I choose to share are kept in the members' library, so you can watch them after the session as well.
New tools, webinars and trainings open to members before they open to everyone.
Once a quarter I hold a members-only session, and you can bring any quality or regulatory question to it.
The first modules of each course are open to members, so you can see how it works before you decide. Your courses, progress and certificates wait in your personal area.
A personal regulatory calendar
A countdown to your audit
My library
My results
Webinar recordings
Early access
A members' Q&A session
Courses and certificates
Three steps, and it's ready
We send you a sign-in link. There is no password to remember, and each time you want to sign in, we send you a new link.
Pick the European Union, the United States or MDSAP, and if an audit is coming up, add its date as well.
The calendar, the countdown, the library and your results are in one place, and they update themselves.
Leave your email address
Choose your markets
Everything waits in your personal area
Using every tool, with the result on screen
Articles, dates and trainings
The full explanation of a result, saving it and a PDF report
The regulatory calendar in Outlook or Google
A countdown to your audit, with reminders
A library and webinar recordings
Early access
Anyone who visits the site can use the tools, read the articles and follow the dates. The club keeps what you have already found and fits it to your markets.
The tools and articles stay open to everyone
yes
yes
no
no
no
no
no
Open to everyone
More about me
I have worked in medical device quality and regulation for over 20 years, and I am a lead auditor. Everything I write and build on the site is open to read, and the club keeps it for you and fits it to what you need.
Sharon Resnick
Your personal area has a personal link. Everyone who joins through it and confirms their email address counts toward your discount, and a colleague counts only after actually joining. The discount is applied automatically when you order a course for yourself, and it can be used once.
Every colleague who joins through you counts toward a course discount
10% off a course of your choice
50% off the list price of a course
One colleague
Three colleagues
No. Paid products are in the shop, and club members get early access to new things before everyone else.
Nothing changes with the newsletter, and you keep receiving it. Joining the club adds the personal area, and the newsletter becomes one of the switches on your member card.
No. Each time you want to sign in, a link is sent to your email, and one click opens your personal area in that browser.
Only your email address is required. Everything else you choose to fill in is used to fit the calendar, the reminders and the content to you, as described in the privacy policy.
Yes, at any time, from your member card. Leaving deletes your membership, your saved results and your library, and you can also download all your data before you go.
The club is for anyone who works on the quality and regulation of medical devices, whether you manage the quality system, prepare for an audit or lead a company toward its first certification.
Does joining cost anything?
I already receive the newsletter. What changes?
Do I need a password?
What do you do with my details?
Can I leave?
Who is the club for?
Questions about the club
It takes one email address, and the personal area is ready a minute later.
Join circle.
Save
Hi
Leave the club and delete my details
Saved
Download all my data
Back to my personal area
Add to my calendar
Download a PDF report
About you
Sign out
Sign-in links and gifts are always sent, because they are part of the service.
Notified body audit
Your calendar subscribes to the dates and updates itself. The link is personal; please don't share it.
Gift
Go to toolbox.
Copy
Everyone who joins through your link is counted once they confirm their email.
Want to go over this result together? Book a call
circle. member report
Audit preparation reminders
Early access
FDA inspection
Set the date
There are no upcoming dates in your markets yet.
My regulatory calendar
A new address
Open
We'll email you a sign-in link, so no password is needed.
What you download from the site while signed in is kept here.
My library
Watch
EU MDR
Israel (AMAR)
United Kingdom
FDA
Bring a colleague
In your calendar
Your dates
When you use a tool, the Save button keeps the result here.
Run again with changes
My results
Go to the tools
Your next audit
Before certification
We will not send you emails about courses and products. Sign-in links, reminders you asked for and emails about your orders still arrive as usual.
Tool update alerts
Courses and products that fit me
days, on
Your next audit
The countdown and reminders are built from this date, and it goes into your personal calendar.
Add to Google
A change of address is confirmed by a link sent to the new address.
This is already your address.
A confirmation link was sent to the new address.
Signing you in…
{n} days of access from your first visit
This link is not active.
Access is for members of circle., the site's members' area. Joining is free of charge and takes only your email address: we send you a sign-in link, and it brings you straight to the first lesson.
Something went wrong. Please check the address and try again.
My markets:
Copied
joined through your link
On qualityworks.pro
Email me a reminder 7 days before each date
Remove from my calendar
Delete
The result
Other
Something went wrong. Please check the details and try again.
Open
Saved in your results.
Emails
Not a member yet?
You will not get these emails anymore
MDSAP audit
Add to Outlook
All courses
Please check the address and try again.
This address already belongs to another member.
Your welcome gift:
Join
Email me when a course or product fits me (one email at most, never a series)
Invited and not confirmed yet:
Your answers and the details
What this means for you
We couldn't find this result.
Sources
Save to my results
A name for this result
Markets and product
Join circle.
Already a member? Sign in
If this address belongs to a member, a sign-in link is on its way to
Enter the email address you joined with, and we'll send you a sign-in link.
See the rules that led to this result, the references to the source documents and the next steps, and save the result with a PDF report. Joining costs nothing.
Change the date
Sets the currency and VAT in the shop.
Finished, with a certificate
Team places
My details
Only your email is required. Everything else helps fit the calendar, the reminders and the content to you, and you can change it at any time.
Change
This link has already been used or has expired
See courses and trainings
Welcome
Download
Purchase
MDSAP
You haven't chosen markets yet.
QMS package
Regulatory tool
saved on
Quality
Sign in to circle.
This link is not valid. You can turn the option off in your personal area.
The full explanation is waiting in
Welcome to circle. A few details help fit the calendar and reminders to you; only your email is required.
Your courses and certificates will appear here.
My courses
My details
This link has expired
Open for you from the newsletter
Opening your lesson…
Leaving deletes your membership, your saved results and your library. Do you want to leave?
Joining gift
Webinar recording
Update alerts are on. If the rules behind this result change, you will get an email asking you to run the tool again. Alerts help you keep track; regulatory monitoring and regulatory decisions remain your responsibility.
Send me a sign-in link
As your audit gets closer
When something new opens to members before everyone else
The newsletter
ISO 13485 certification audit
A link to confirm your address and sign in is on its way to
Update alerts are off. You can turn them on in your details.
You can add these dates to your circle. calendar, which appears in Outlook or Google through the calendar link in your personal area.
Members club
Course with a certificate
The result is based only on your answers and on the rules of the tool on the day you saved it. It is general information; regulatory monitoring and regulatory decisions remain your responsibility.
An email when the rules behind a result you saved are updated.
One email at most when a course or product fits what you did on the site. Never a series.
lessons
This one
The full training
Send me the newsletter too, every two weeks
Check your inbox
Management
Regulatory
Certified and on the market
Enter its date, and the countdown and reminders start.
Pick the one that is most useful to you right now. It goes into your library and to your email.
IVD
with email reminders
510(k), De Novo or PMA
When is your next audit?
Each sign-in link works once. You can ask for a new one.
Choose your welcome gift
Go to the course page
Software (SaMD)
Reminder emails are on.
The newsletter link was open for a limited time. On the course page you can still see what the course covers and the lessons open to every circle. member.
Modules
Delete this result?
Quality and regulatory manager
Every two weeks, regulatory updates and what matters about them
Reminder emails are off.
Active device
PSUR frequency
Implant
Non-active device
MDR classification
Reporting deadlines