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Sign up to get FREE access to our agile regulatory templates and RIM/ALM tooling that have been refined, rewritten, and battle tested for 12 years on over 30 FDA submission.

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Not just templates. 

Not just software.

It's a full operating system for preparing and submitting an FDA application


Don't delay your submission. Use the same templates and software we have built over 12 years and used on 30+ submissions, including SaMD, SiMD, and AI/ML.

Brought to you by the all star team

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What will I get?

Regulatory Information Management

Think of this like your database schema for all things regulatory. It is way easier to edit the data model directly rather than the terminal Word documents—which are more like "views" into the data model.

User Needs and Requirements

eSTAR in one click

Export all the documents you need for an eSTAR submission in the format FDA expects them without having to get a degree in regulatory sciences.

Cybersecurity

You'll get access to our cybersecurity templates including the security risk management plan, vulnerability management SOP, and security risk database. 

Edit Once

Your intended use statement will likely change many times during the development process and is likely to change during FDA review in response to reviewer feedback. This can be a HUGE pain to edit every single copy of your intended use statement. The FDA has rejected applications with such inconsistencies.

Test Management System

You can capture your test (both validation and verification) cases, test steps, and link to requirements. You can also capture the test run results in Notion. All results will be pulled into the relevant documentation for the FDA submission.

Risk Management

Capture all your hazards, hazardous situations, probability, and severity in one table. Automatically calculate the risk classification. Easily trace to requirements 

Checklists

A lot of template libraries just throw templates at you without much knowledge on how to start. We provide you a concise checklist of tasks, when complete, will generate everything needed for an FDA submission.


Checklists Demo

Technical and Clinical Performance Assessment

Got AI/ML? Need templates? Why not start with ours?

Templating

Slice and dice the regulatory data model however you like with our customizable templating language. This allows you to decouple your presentation layer (the eSTAR docs) from the data model so you don't have to redo everything if FDA requests you change the way you present your documentation.

Customizable Exports


Project Management

Notion offers a range of project management tools, including task management, timeline and calendar views, Gantt charts, and to-do lists. Medtech OS seamlessly integrates these tools into the different Product Documents, simplifying and centralizing the management of your medical device project. This integration ensures that all aspects of your project are efficiently managed from a single platform.

API


Notion has APIs that allows you automate tasks, imports, and exports.

 Word Export


Once you are ready to submit, our system exports Word documents so you can fine tune presentation or store the documents in a document control system. 

PDF


You can convert the Word version to PDFs for eSignature if desired. The paid version includes part 11 compliant signatures—which is not needed for a 510k or De Novo.

OTS / SOUP Template

You can potentially spend hundreds of hours going overboard in interpretation of OTS guidance. Just follow our tried and tested formula to prevent that.

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User Manual Template

You need a user manual but there is not much guidance online for the contents. We make it as simple as just filling in an outline


Templates Demo

The Goal

Our tool helps you write all documents necessary for an FDA submission

The Team

What is an even faster path to market than a DIY tool? Hire the dream team.

FAQs

Why not give immediate access?

Each new install of Medtech OS requires resources from our team to onboard your instance so we are limiting the number of installs per month so we won't get overwhelmed.

Is it really free?

Yes. It includes everything you need from 0 to your first FDA submission. Our consulting services and paid versions are optional.

How can you make money if you give it away for free?

Once you get FDA approved, you will likely need additional features that are available in the paid tiers. Also, we offer paid support through our regulatory and engineering consulting services.

Can you submit my application once it is done?

Yes! Regulatory consulting is not included in the free tier but rest assured we can help you if needed. 

What if I get stuck?

We are here to help. Unlike other regulatory software solutions, we have full time regulatory consultants and medical device software engineers ready to help you out.

Can you just write my 510k for me?

Yes. Hire the dream team behind this 510(k).

Do I need to buy a Notion subscription?

Notion has a free version that appears work well. However, most of our clients buy a Notion plus plan which is $9 per user per month. 

When will I hear back?

It depends on how many people signed up ahead of you. Refer your friends with the referral link to jump ahead in line.

Are there any limitations?

Our free license requires you to add an unobtrusive link in your 510k summary pointing to innolitics.com.

I am a regulatory consultant. Can I use this?

Yes. You may use it and refer your clients to it. You may want to consider joining our affiliate program so you can be appropriately compensated for Medtech OS subscriptions referrals.

What if I already have a tool?

You won't lose anything by evaluating the free version. Plus, Notion has a flexible API that can make migration a breeze.

Do you offer technical support?

We will fix bugs in our software. However, errors caused by user error such as accidental deletion will incur our hourly consulting fees.

What is the inclusion criteria?

We are looking for people that are open to using new tools and are serious to give the tool a shot all the way to an FDA submission and beyond. SaMD is preferred but SiMD is also considered.

What is the exclusion criteria?

Your device needs to have a strong software component. A hardware only device like a tongue depressor, for example, is likely not suitable.

Is there anything I can do to increase my chances?

Yes! Optionally, please share your referral link with your network to be moved up the list.

One more thing...

Spread the word to be selected sooner


Why Share?

We pick the top applicants per month. Applicants with the highest score are chosen first. You will receive a point every time someone signs up using your link.


Sharing is caring.

You would be bummed If one of your connections knew about this and kept it to themselves. Right?


What are you waiting for? Your FDA clearance awaits.

We have learned a lot from the community in the last 12 years. Now we would like to give back to pursue our mission to accelerate progress in the medical device industry.