Bring FDA and ISO-compliant medical devices to market... less time
...for less money
...and without the risk of an audit going sideways.


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Can you answer “Yes” to these questions?

  • Do I have traceability throughout my entire system?

  • Are my employees and consultants focused on high-value tasks?

  • Am I able to launch a medical device as fast as the market leaders?

  • Is risk management visible throughout my entire product lifecycle?

  • Am I ready for significant changes in risk management and ISO 13485:2016?

  • Is my QMS centralized vs. scattered between multiple tools and piles of paper?

  • When I get audited, can I present required documents and signatures on demand?

  • Is my QMS as efficient and cost-effective as possible?

If you rely on a paper-based QMS, legacy eQMS or no QMS at all

you will struggle with all of the above.



A disorganized and inefficient QMS slows your time to market...

...while you waste thousands of dollars on additional employees and consultants trying to pick up the slack.

And it gets worse.

There is also the possibility of unannounced FDA inspections and ISO audits — especially within the first 2 years of bringing your device to market. When you can’t immediately demonstrate compliance, audits are expensive and take your focus away from your product.

Common issues such as missing signatures and documents can waste 100's of hours over the course of a single project. You may even walk away with a warning letter.

Fortunately, there is a better way.


Launch sooner, be compliant and cut costs

With, documents and records required to demonstrate compliance with regulatory requirements are always organized, up-to-date and available on-demand in a platform designed for Part11 compliance.


Get to Market Faster

Processes that slow your time to market such as document routing, reviews, edits and signatures are done electronically in one always accessible place.


Be Compliant & Reduce Risk

Each feature is built to ensure you follow FDA 21 CFR Part 820, ISO 13485 and ISO 14971. FDA inspections and ISO audits are smooth and less stressful.


Implement quickly

Unlike a paper-based QMS or legacy eQMS, you can have set up in days, not months — no expensive training required.

See how can help you move fast, reduce risk and prove compliance.

Show Me How It Works

Everything you need to bring
safer medical devices to market in less time


Ultimate Guide to Design Controls for Medical Devices

Get valuable insights to explain what Design Controls are, how to address them and how they benefit your medical device product development efforts.


a guide by:
-Jon Speer, Founder & VP of QA/RA

Read the Guide (no email required) >


Step-by-step Guide to Complying with ISO 13485 & FDA QSR

Use this step-by-step guide as a tool to help you with your QMS efforts, identify gaps in your current QMS and structure your internal auditing program.


a guide by:
-Jon Speer, Founder & VP of QA/RA

Read the Guide (no email required) >


How to Prepare for the New EU Medical Device Regulations (MDR)

Learn about all the significant changes to the new European Medical Device Regulations and how to begin preparing for compliance.

Free Live Webinar - Oct 27th 11AM ET / 4PM GMT

Register now >

Ready to see for yourself what makes so different?

Schedule a call and live demo of to see if we're a good fit to help your company.


Yes, I Want a Demo!

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