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OTC SaMD Wearable Development and Clinicals

CRO Group, with SaMD/Wearable experts in both Boston and Silicon Valley, is a leading development and regulatory consulting organization.  Our team brings a wealth of experience in using software project management and development tools and analyzing and adapting your process with the IEC 62304 SDLC (software development life cycle) requirements recognized by FDA and essentially required by EU Notified Bodies.  Our unique swim lane process merges QSR (21 CFR 820), ISO 13485:2016 7.3 Design Controls, ISO 14971 Risk Management, and IEC 62304 SDLC with AGILE/SCRUM for iterative development and proportional risk design documentation, and in meeting regulatory agency add-on requirements – for example cybersecurity.

We have also been valuable in sorting out the often complex App functionality vs. clearance and or approval requirements in the USA, EU, Canada, and other regions and countries.  Careful planning of App functionality and submission label claims can make the difference between unregulated vs. 510(k) vs. de Novo vs. PMA, and between a Class IIA and IIB under the MDD, and between the new product classifications under MDR and IVDR.

In addition, for wearables, particularly those with body contact electrodes and or specific use indication, CRO Group functions as the compliance engineer of your hardware design team, so that design requirements address the relevant IEC 60601 standards at the start vs. the end of project.

Finally, with regard to OTC vs. Rx only use indications, and IVD/CLIA, CRO Group is proficient at mapping out the strategy for Q-Subs, as well as study design and implementation of Label Comprehension, Usability Engineering according to IEC 62366, Safety and Efficacy Clinicals and or Clinical Evaluations according to MEDDEV 2.7.1 Rev 4 as well as the additional significant clinical requirements under the MDR and performance evaluation requirements under the IVDR.

For a complimentary no-stress introductory web meeting to review your project, fill out the web form below.