Making medical apps to be reliable, not risky


Based on the wide ranging variety of digital health apps and the changing landscape, it appears that at some point FDA may be required to have more regulatory oversight than currently is the case in this space. #FDA #510k #regulatoryaffairs #medicaldevice #meddevice #medtech #digitalhealth #healthtech #healthapps 

see full article here:

Thomas Regulatory Resolutions (TRR) is a lean medical device consulting firm serving the medical device industry by providing value-added consulting services to medical device manufacturers for FDA submissions, FDA Compliance 510(k), Establishment Registration, FDA US Agent, CE Marking per EU MDR 2017/745 and Clinical Evaluation Reports (CERs) per MEDDEV 2.7/1 among other regulatory services.

Count on us for all of your medical device regulatory submission needs.

You may contact us via phone at +1 561 898 0260 or email or if you are ready now to schedule a free 30 minute appointment with us, please do so here: and we are standing by to support your medical device regulatory and compliance needs.