Welcome

We integrate with your eQMS and using a Large Language Model (LLM) AI model, we determine what is and is not in your QMS.  Then we consolidate and prioritize the insights to show you too so the most impactful and important patient-impacting ones are shown first.

Other formats of sharing your QMS documentation are also available such as Dropbox or manual.

Here's a flavor of what we could find:

• If you are missing warranty reliability specifications or testing best practices
• If your SaMD DHF doesn't mention a FDA cybersecurity requirement
• If you claim conformity to ISO 14971 but are missing clause 6.1's requirements

Coming soon....  industry-comparison actions:

• If your risk-acceptability threshold is very low vs. other companies
• If you have too many approvers for document changes vs. other companies 
• If you have too many CAPAs opened or software bugs opened vs. other companies

We use the industries best experts and have a thorough design, testing and release process for our Quality Evolution model.

By the end of 2024, we will have more than 10,000 questions in the maturity model and it's growing!  This equates to over 40 audit days worth of assessment from the range of experts than 1 auditor could never achieve alone. 

We will provide references to where any compliance gap or quality best practice is generated from.  We can also point you in the right direction if you are not sure how to implement the recommended action identified!

You should never blindly accept all recommendations.  You can mark recommendations as not applicable, hide for consideration later, mark as actively addressing and as complete.  Your Quality Evolution ranking vs. other companies will increase as recommendations are implemented.

Coming soon, we will tell you what percentage of other, similar companies have implemented the recommended action we are saying.  Don't just take our word for it!!

YES !!

We only have read-only access to your QMS.  We do not store copies of your QMS documentation locally.

The LLM is not saving your input and is not using your QMS as part of its training.

Ryden Solutions works with clients of all sizes, from small businesses to large corporations. We also work with non-profit organizations and government agencies.

We work with all Healthcare and MedTech companies that have to comply with USA FDA, EU Medical Device Regulation (MDR), and ISO 13485 among other requirements.  This includes diagnostic AI software as a medical device (SaMD), large equipment, surgical tools, disposables, pharceuticals, etc.

Access to the Ryden App is for a 12 month contract.  

Although one-time quality assessments are available, most clients use Ryden Solutions to max value by monitoring their QMS for Quality Evolution over time.  The Quality Evolution is alway sadding more topics and questions to the model.  Additionally it will always test the latest regulatory requirements.