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Using the Roadmap features
FREE mHealth Checklist and webinars offer an overview of the US rules and regulatory requirements for mHealth devices. Our mHealth Regulatory Guide is a detailed list of the relevant regulations, and explanations of the specific regulatory requirements.
Search with ease and sophistication. Numerous agency datasets have been extracted and organized, so you can conduct a broad search across all data sets, or a narrow targeted search in the specific section using natural process language mapped keywords.
Apply the same features as Search, and then select to compare medical devices for similarities and differences. The side-by-side comparison on one screen, with the ability to select which specific data elements to compare, give you the ease to quickly learn from the market.
We’ll show you the many possible routes to device approval and monetization so you can evaluate, plan and execute.
Once you have found the device information and pathways, we’ll aggregate all the information reducing time to identify and compile, which means reduced time and lower costs.
Customize alerts to your specific preferences. Choose the device, markets or actions you’re interested in monitoring, and we’ll deliver personalized, and real-time alerts directly to your Twitter feed or email inbox.
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News and Resources
News & Announcements
DRAFT - technical considerations specific to devices using additive manufacturing (3D printing) Congress Suspends Medical Device Tax for 2 years FOR IMMEDIATE RELEASE: ClearRoadmap selected as StartUp Health: Entrepreneurs Transforming Healthcare Preferred Provider. Infrastructure, Patients and Quality are FDA CDRHs strategic priorities For Medical Tech Startups, FDA Approval Is Crucial FDA Releases: Pilot Program for Medical Device Reporting on Malfunctions Cook Medical - BEACON® TIP ANGIOGRAPHIC CATHETERS RECALL - AFFECTED LOT NUMBERS ClearRoadmap Accepted into Microsoft Vertical ISV Partner Program Loudoun County Board of Supervisors approves CEO, Vizma Carver's nomination for the Loudoun Health Council - located just outside Washington DC, and is the first health department in Virginia to be accredited by Centers for Disease Control (CDC) Public Health Accreditation Board. 510k Defibrillator + Drone = Flying Ambulance to save lives! Results of the 2014-2015 Strategic Priority: Strike the Right Balance between Premarket and Postmarket Data Collection FINAL GUIDANCE: Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance: FDA Decisions for Investigational Device Exemption Clinical Investigations Guideance: IDEs for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies 23andMe makes progress with FDA FDA CDRH - Mobile Medical Applications Guidance Medical FDA CDRH - DRAFT Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types days FDA CDRH -DRAFT General Wellness: Policy for Low Risk Devices CDRH Customer Satisfaction Rating FDA licenses first medical device for Migraines Are Mobile Devices the new "normal" in Healthcare?
Blog
Lessons Learned from the Medical Device Industry: Part IV Labeling Operation and Troubleshooting Lessons Learned from the Medical Device Industry: Part III Labeling Description Lessons Learned from the Medical Device Industry: Part II Tools to Learn From Others Lessons Learned from the Medical Device Industry: Part I Quality is all about the User Experience Changes at FDA to drive consistency in field inspections FOR IMMEDIATE RELEASE: ClearRoadmap™ launches Web-Service API for in-depth analytics on medical devices Clinical Trial Design becoming the critical component to success ​​​T​he Importance of FDA Medical Device Information for your IOT Connected Healthcare Solution Don’t believe those that tell you tracking down FDA regulatory classification for your product requires time and perseverance FOR IMMEDIATE RELEASE: Carver Global Health Group LLC accepted into Microsoft’s Vertical ISV Partner Program for its ClearRoadmapTM product. FDA CDRH leading patient preferences in regulatory decisions – personalized medicine here? AppleWatch mHealth apps avoid FDA medicaldevice Regs. leveraging existing FTC regulated Fitness & Smartphone apps Will mHealth, #HealthKit, #ResearchKit change the landscape for patient informed consent, HIPAA, and patient preferences? Authentication vs. Repudiation in IoT and mHealth: weaknesses in Apple’s ResearchKit Microsoft’s HealthVault Google’s FitKit Is Mr. Spock’s departure just a loss to Star Trek legacy or does it also mark a new era for healthcare? Can Internet of Things (IoT) learn from George Orwell? Accelerate Your Innovation The online presence that is most important for medical technology adoption. Accessories can now be an accessory to health care innovation! For medical devices are the Alps higher than the Rockies? Reimbursement is the Elephant in the room, not FDA Approval or CE Mark FDA Expanding their Reach into mHealth.... Really? Medical Device Regulators Trimming Costs for Medical Device Companies