Sorry to be gone so long. While we were away we improved ClearRoadmap medical device data and helped MDIC and FDA realize the value of quality

As you can see from our websites new face, we have been a bit busy!

If you have not already looked at how ClearRoadmap data can support cyber security risk management, then visit our home page for a quick diagram.

This is possible with the ClearRoadmap API.  You can now connect your favorite business intelligence tool and run the analytics on ClearRoadmap data.  Since ClearRoadmap has extracted out of the FDA medical device and biotechnology Summary of Safety and Efficacy PDF documents, and correlated with each devices Clinical Trials.gov data, you can run your own analytics.

Many of you also asked for the MAUDE data.  We heard you and added the MAUDE Adverse Events to the ClearRoadmap database.  The data is currentlyaccessible with the API, and soon to have a web interface.  With the MAUDE Adverse Events module we added the MAUDE data to the comprehensive device data.  This means you have the ability to search using keywords or free text in the MAUDE data, or add other context, such as Indication of Use and Adverse Effects.  Yes, we have linked  the MAUDE data with the devices known Adverse Effects and Indication of Use.  So go to town and do your research!

The complexity of the ClearRoadmap database require process to maintain quality.  It is in the right processes and their sequences that enables us to deliver data in efficient and effective manner.

The concept of the right processes and their sequences as a framework for quality is nothing new.

This past fall I had the privilege to co-lead the team that evaluated CMMI (Capability Maturity Model Integration) as a maturity model that FDA CDRH and industry can embrace. The future looks promising!  In the future blogs I will discuss my experience with CMMI.

Vizma Carver
Founder and CEO