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.


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

Quality Management Software

Trust the only cloud-based eQMS made for medical device companies to provide a single source of truth for your team, processes, documents and records.

Design Control

Prove to regulatory bodies that you have met design requirements with hassle-free design control documentation, complete traceability and on-demand DHFs.

Risk Management

Comply with ISO 14971 and other industry standards by making risk management an important part of your entire product lifecycle.

Document Management

Get organized and be audit-ready by managing your controlled documents, records and SOPs in one convenient place.


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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 Simplify Your Compliance to the New ISO 13485:2016

Learn about all the exact changes along with step-by-step instuctions on how to simplify your transition.

Tuesday, October 4th at 12pm ET / 9am PT

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Startup Fast Lane Program

See if you qualify for a steep discount on software. We have a new program designed especially for seed-stage medical device startups.

Learn more about our Startup Program >

We Partner With Consultants is more than just eQMS software. See how partnering with us will help you grow your business.

Learn more about our Partnership Program >

Quality & Regulatory Services

Our gurus are medical device professionals with proven track records of helping hundreds of device companies achieve & maintain their regulatory compliance.

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