Get your MDR compliance done, step-by-step.

Successfully done by 20+ startups.

Watch this video to see how it works:

Since we brought our regulatory software, Formwork, to market, I've been showing it to many startups.

But there's one problem: Startups don't understand MDR compliance, and they don't understand how regulatory software can help them achieve it.

Instead, they expect a magical tool that miraculously makes them compliant.

So we thought: Why not build that tool?

And now it's done: The Formwork Wizard.

Dr. Oliver Eidel

Managing Director and Soccer Mom at OpenRegulatory

Introducing the Formwork Wizard.

A predictable, self-guided step-by-step program
for startups to become MDR-compliant.

Why?

During our consulting, we noticed that most of the stuff we do is highly repetitive: We're pretty much explaining the same documents all the time. This sucks because it's boring for us and inefficient for our clients.

We asked ourselves: Can it be automated? Like, an automated consultant?

And the answer is yes!

The Formwork Wizard is like an automated consultant which explains you how to create your documentation. It's much cheaper than a "real" consultant and you can work at your own pace.

How Does It Work?

On the right side, the Wizard gives you a document editor with one of our templates preloaded in it. On the other side, the Wizard displays a video in which we explain how to fill out the document.

Each step in the Wizard is short and easy to follow - typically, videos are somewhere between 5 and 12 minutes in length.

What Does It Include?

The Wizard covers compliance for ISO 13485, IEC 62304, ISO 14971 and IEC 62366. Additionally, there are videos for BfArM product submissions.

How Much Does It Cost?

The Wizard is included in Formwork Plus which costs 149€ per month plus applicable AT. Yes, that's right - it's super affordable.

It's billed monthly via credit card and you can cancel any time by pushing a button. I mean, you could literally purchase it for one month and only pay 149€. Not that I would recommend that..

It also includes unlimited user accounts for your company, so you can invite all your colleagues to go through the Wizard.

How Can You Get Access?

You can purchase the Wizard now and get access right away! If you don't have a Formwork account, register now, then head over to Settings --> Billing and upgrade to Formwork Plus. You can find the Wizard by clicking on "Wizard" in the top menu.

Ready to Get Started?

After registering on Formwork, navigate to Settings - Billing.

Register and Purchase Now

Features

Frequently Asked Questions

Will I still need a regulatory consultant?

Yes, probably. But it's very likely that you'll save you a ton of money because you don't have to pay a consultant to teach you all the regulatory basics. Instead, you can spend your money wisely on getting specific answers to tricky questions. I like to say that the Wizard gets you 90% there, and the 10% are tricky and often need a human consultant. A bit like creating tax returns with software.

Can we also use this for internal training? Does it generate a PDF certificate?

Yes! After watching the Wizard videos, you can download a PDF certificate which lists your achievements. You can use that as proof for employee training in your QMS.

How much does it cost?

149€ / month plus applicable VAT.

Does it really have unlimited users?

Yes. We don't believe in per-seat pricing. Everyone in your company can access the Wizard while you only pay one flat price.

Ready to Get Started?

After registering on Formwork, navigate to Settings - Billing.

Register and Purchase Now

What's in the box

List of All Wizard Steps

IEC 62304

Software Development

The IEC 62304 is about documenting your software and establishing processes which ensure that your software development is compliant. Among other things, that includes documenting your software requirements, software tests and libraries (SOUP - software of unknown provenance).

7:06
Introduction
10:15
Meet CrowdCovid
7:33
V-Model and Compliant Development
12:12
Writing a Software Development and Maintenance Plan
4:13
Why Software Requirements?
24:23
Writing Software Requirements for CrowdCovid
8:16
Software Requirements Review
21:51
Software Architecture Documentation
12:29
Implementation and Verification
13:00
SOUP (Software of Unknown Provenance)
16:44
Software System Testing
8:03
Release
7:41
Change Management
3:42
Problem Resolution

ISO 14971

Risk Management

To be compliant with ISO 14971, you need to perform a risk analysis of your device, as well as establish risk management processes in your company.

12:51
Creating a Simple Risk Table
19:18
Risk Acceptance Matrix
6:17
Preliminary Hazard Analysis
19:21
Failure Mode and Effects Analysis (FMEA)
18:03
Failure Modes
17:30
Risk Control Measures
5:22
Risk Management Plan
11:40
Risk Management Report
10:59
Risk Management in SOP Integrated Software Development
8:35
Improvements to Risk Management

IEC 62366-1

Usability Engineering

The main chunk of work for IEC 62366-1 compliance is performing usability tests with users. With those, you prove that your product is actually usable.

5:42
Getting Started with the 62366
13:22
List of Hazard-Related Use Scenarios
4:22
Formative Usability Evaluations
14:44
Preparing the Usability Evaluation Protocol
12:12
Doing the Summative Evaluation - Usability Test
9:16
Usability Evaluation Plan
13:47
Usability Evaluation Report
8:10
Usability in SOP Integrated Software Development

ISO 13485

Setting Up Your QMS

Sven shows you how to set up your Quality Management System (QMS).

11:39
Quality Manual
6:35
Internal Audit
10:46
Document and Record Control
7:08
Management Review

MDD

Medical Device Safety Officer Training

For the old legislation in Germany (MDD / MPG), you needed a so-called Medical Device Safety Officer. That person needs to have an idea of what his/her obligations are. You can use these videos to teach yourself and create a PDF certificate.

4:45
Introduction
9:02
Legal Requirements
15:42
Tasks and Responsibilities, Example
4:13
Examples
2:50
Conflicts of Interest, Liability
6:48
External People, MDR Outlook

MDD

Medical Device Consultant Training

Similar as the Medical Device Safety Officer, the MDD / MPG had a requirement for so-called Medical Device Consultants. Typically, those are your salespeople and people in customer support. They also need to be trained.

10:40
Requirements, Tasks, Responsibilities
9:39
Examples

Germany / BfArM

BfArM Registration

For one of our customers, we brought a medical device to market. That gave me the unique opportunity to walk you through the process of navigating the slightly confusing BfArM / DIMDI registration system!

10:18
Getting a User Code
11:02
Company Information and MDSO
11:26
Submitting Your Product

Ready to Get Started?

After registering on Formwork, navigate to Settings - Billing.

Register and Purchase Now
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