Practical help for your quality and regulatory work, ready when you need it
Here you will find what I have built from more than 20 years of work with medical device companies: reports that show you where you stand, certificate courses you take at your own pace, and a yearly training plan for your whole team. Every item opens a page with the full details, and you order it there.
See Quality Year
See a first look at your code
Build your package
Coming soon
22 short trainings, English or Hebrew per employee
The yearly quality training every employee needs, without building it yourself. Each employee gets the short trainings that fit their role and a certificate at the end of the year, and you get one training table for the whole team, ready for the audit.
For a team of more than {n} employees, I will send you a price based on its size.
Quality Year
Certificate
FDA, Sent by email
Planning a 510(k), or watching a competitor? This report shows what the FDA's public data says about your product code: who holds the clearances and how long FDA takes to review them, what your competitors tested and claimed, and where the adverse events, recalls, inspections and import refusals are.
FDA market intelligence report
For teams
ISO 13485, EU MDR, FDA, MDSAP
A complete set of procedures, forms and role trainings for your quality system, adapted to your company from a short questionnaire, so you start from documents that already fit the way you work.
QMS document package
Start the check
{price} with Quality Year
Choose a course
Leave your email and I will let you know when it opens.
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See the lessons and order
A report on up to three product codes, with charts and a short explanation under each A check of your own FDA records, when you name your company The data as an Excel file, usually within an hour of the payment
About {n} hours
Launch price {price} (regular {list})
Coming soon
Training for the whole company, with records you can show the auditor.
Your email
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Launch price until {date}
Courses
Reports
ISO 13485, About 15 minutes
An audit coming up? Answer 48 short questions that follow what the auditor will ask to see. You get your readiness score and your three most serious gaps right away, before you decide to order anything.
Audit readiness report
Any course
Training several people on the same course? Order the seats you need in one order, then assign a learner to each seat from your team page. Every learner studies separately and receives their own certificate.
Course seats for your team
For teams
Let me know when it opens
Certificate courses built on real situations from medical device companies. You study at your own pace, can listen to every lesson if you prefer, and finish with a final test and a certificate.
Ready-made products
You will be able to
per employee a year
Every gap, why it matters and the evidence the auditor will look for What to fix first, in a plan up to the audit date A second check within 90 days, to see what you closed
A clear picture of where you stand, so you know what to do next.
{n}-month access
Courses
Templates and kits you can download and use right away.
teams of {from}–{to}
Reports
Launch prices until {date}
Ready-made products
Lifetime access
What you receive
The full report adds
The first products are on their way. Until then, you're welcome to ask me about them.
Build your package
Complete kit
Procedures for ISO 13485, EU MDR, FDA and MDSAP with their forms, templates and role-based trainings, selected by nine questions about your markets and your product. You can order the full package or single procedures.
A complete quality system for your company
See the plans
Guide
Product
AI agents that work with you on CAPA, procedures, audits, the technical file and more, in three plans.
Recorded course
Document review
QMS package
A subscription to the AI agents for quality and regulatory work
Procedures package
Template
Training
Checklist
A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.
Let's talk about your device
hours
Preparing your download…
The receipt is sent to your email after the payment.
Who it's for
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Your download
Done. The download link is on its way to your email.
Live session
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and the
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Download
Leave your name and email, and the download link will reach your inbox within a minute.
Thank you. Your order number is {ref}, and the next step is on its way to your email.
Name
terms of sale
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Send it to me
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Leave your details, and the download link will reach this email address after the payment.
Format
license terms
The materials are licensed for use within one company. You may edit and adapt them for your own quality system, but you may not resell, share or publish them outside your company.
Place the order
I've read and accept the
License
Company (optional)
Country of your company
Prefer to do this together?
Thank you. I'll let you know as soon as it's available.
What's included
Recording
Training details
This one isn't ready yet. Leave your details and I'll let you know when it's available.
Let me know
No
Yes
Answer nine short questions about your markets and your product. The procedures, forms, templates and trainings that apply to you appear as you answer, together with the price, and you can order the full package or single procedures.
A quality system for ISO 13485, EU MDR, FDA and MDSAP, built for your company
Everything else, such as company details, roles and the systems you use, goes into the full intake after the order, already filled in with these answers. The US (FDA) content is included unless you tell us otherwise there.
About your company
A procedure in this package
The download link is on its way to your email.
Download a procedure, a form or a training from the package and compare it with what you have today. Leave your name and email, and the download link reaches your inbox within a minute.
You save {amount} ({pct}%)
{n} days left
ISO 13485 with EU MDR, FDA and MDSAP content, selected by the markets you sell in
Built with your company name, roles and settings from the intake
Who decides, by which criteria, and what is recorded at each step
The forms, templates and logs of each procedure are included
Role-based trainings with a knowledge check and a training record
Each procedure names the procedures it receives from and passes to
Every requirement in the procedures is covered by a form, log or other record, so you can show it was done
How a procedure in this package differs from a typical template
Markets
Sample available
See the quality for yourself
Your selection
Total
Buy this procedure on its own
Here you can see what your company purchased, until when your updates are included and what a renewal costs. You can also renew the updates, add procedures or update your answers when something changes in your company. The link to this page is personal, so please keep it within your company.
Your customer card
Updates included until
Thank you. Your order number is {ref}, and the payment details are on their way to your email.
Name
These procedures do not apply to your answers.
Send me the link
terms of sale
What you purchased
What you get
A typical template
Choose your procedures
Single procedures
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Not part of your package
Tick the procedures you need. Single procedures are priced one by one, without the package discount.
Before you order
Annual updates
I've read and accept the
Your updates have ended. The documents remain yours to use.
Customer card
The full package
Sign out
Single procedures
ISO 13485 clauses
Placeholders for you to fill in
A list of steps
Forms often sold separately
Not included
Each document stands alone
Steps without a record behind them
The procedures in your package
Full package
Continue to order
Send the order
Tick at least one procedure.
Package discount
From the second year you can renew the updates for {amount} a year.
Including VAT
Every procedure that your answers select is already yours.
Your next renewal: {amount} a year
Your documents are delivered within 5 business days from the later of the payment and the complete intake. The adaptation to your company is done from the intake and is included in the price. Implementation in your company is a separate service.
Company
Country of your company
The price is sent to you with the payment details.
forms, templates, logs and work instructions with them
Add procedures
If this address is listed on the card, a code is on its way to it. The code is valid for 10 minutes.
Write to me
If you find an error in a document, write to me with the order number and the document number, and I will correct it at no charge. For help with implementation, reviewing documents you changed or preparing for an audit, support can be ordered.
If there is a customer card for this address, the link is on its way.
Enter the email address you ordered with, and the link is sent to it.
This link to a customer card is not valid. Enter your email address, and the link to your card is sent again.
Procedures added
Your order
Updates included until {date}
Your product
procedures
Bought one by one:
Use another address or ask for a new code
The code is not correct or has expired. Please check it, or ask for a new one.
Need help?
Lost the link to your customer card?
Thank you. Your order {ref} was received, and the payment details are on their way to your email.
After the order you receive the payment details by email, and your card is updated once the payment arrives. Added procedures and documents built again are delivered within 5 business days from the later of the payment and the intake details they need.
Add
If you renew on or before {date}, the new year is added after that date. After it, the year starts on the day of payment.
Already paid for your procedures
Your updates have ended, so a renewal is part of this order.
Move to the full package
Send me a code
To keep your company's documents safe, the card opens with a one-time code. Enter your email address, and if it is listed on the card, the code reaches it within a minute.
Open the card
Your files will appear here once they are delivered.
Your files
Send me the link
Your procedures
Main contact
The card opens only for these addresses, each with its own one-time code. As the main contact, you can add up to 5 colleagues or remove them.
Renew the updates for one more year
Paid
Change an answer, choose procedures or tick the renewal, and the price appears here.
Your answers changed, but no procedure is added. Your documents are built again with the new content for the renewal price, and this counts as your renewal.
Updates for one more year
Your customer card
Your answers from the purchase are already marked. If something changed in your company, such as a new market or software in the device, change the answer and the price updates right away. Procedures you add to a package are priced at your package rate.
Renew or add procedures
Also yours
Send the order
Your orders
Who can open this card
{pct}% of what you paid for documents ({paid})
At your package rate
Form or template
Training
Renew or add procedures
Remove
Procedure
Download
Waiting for payment
Procedures
What you already paid for your procedures is deducted from the package price.
From the second year you can renew the updates for 15% of what you paid, one year at a time.