What regulatory government approvals do health devices need to have?

What regulatory government approvals does health devices need to have?
Dr. Amod Wagh, Founder and CEO of RHEMOS Telehealth, in a conversation with Healthy Wrinkles, explains What regulatory government approvals does health devices need to have?. 
In the rapidly evolving landscape of healthcare technology, regulatory approvals play a pivotal role in ensuring the quality, safety, and reliability of health devices. Aamod Wagh, a trailblazer in this space, sheds light on the regulatory journey his devices have undergone. This article explores the significance of CE approval for wearable devices and delves into the meticulous process of obtaining CE Med certification for medical-grade devices. Watch our YouTube playlist on care for seniors to know more.

Wearable Devices and CE Approval:
Aamod Wagh's wearable devices, exemplified by the Tiger Track and Tiger Fit Pro, have earned the coveted CE approval, a testament to their quality and accuracy. CE approval, mandatory for selling devices in Europe, focuses on electronic aspects rather than medical aspects. These wearables have been embraced in India since 2016, with tens of thousands in use. The regulatory nod from European authorities underscores the devices' adherence to global standards, positioning them as reliable solutions for health and safety.

Usage in Senior Care Companies:
The wearables have found significant integration into the offerings of major Indian senior care companies. Collaborating with these industry giants, Aamod Wagh's devices have become integral components of home care and senior care packages. Offering various plans such as silver, gold, and platinum, these companies provide end customers with a range of services, with the wearables adding value through features like emergency response and communication capabilities.

CE Med Certification for Medical Devices:
Transitioning to medical-grade devices, Aamod Wagh emphasizes the rigorous testing required for CE Med certification. The Remos Health Monitor, designed for comprehensive health monitoring, undergoes a meticulous testing process. CE Med involves comparing the device's readings with gold standard manual devices used in hospitals and labs. The stringent criterion demands a tolerance level of less than one to two percent difference for certification. This exhaustive process ensures that the Remos Health Monitor meets the highest standards of accuracy and reliability.

Acceptance and Impact in Healthcare:
Aamod Wagh's commitment to quality is reflected in the widespread acceptance of the Remos Health Monitor in India. With more than 100 hospitals currently utilizing the device, it is treating over two lakh patients monthly. This widespread adoption speaks volumes about the device's clinical efficacy and its positive impact on both rural and urban healthcare providers. The device has become an invaluable tool in the hands of healthcare professionals, enabling remote monitoring and improving patient outcomes.

Future Implications and Conclusion:
As the regulatory journey continues, Aamod Wagh's devices are poised to shape the future of healthcare technology in India. The seamless integration of wearables into senior care plans and the success of the Remos Health Monitor in clinical settings highlight the potential for these innovations to revolutionize healthcare delivery. Aamod Wagh's emphasis on regulatory compliance ensures that these devices not only meet current standards but also lay the foundation for advancements in the dynamic healthcare landscape.

In conclusion, Aamod Wagh's insights into the regulatory pathway provide a glimpse into the meticulous processes that guarantee the quality and reliability of health devices, paving the way for a transformative impact on healthcare in India.

Whether you are searching for informative articles, or looking for healthcare providers, Healthywrinkles is an excellent resource for all your senior care needs. We also have a great compilation of all the medical expert talks for healthy aging on Healthy Wrinkle YouTube channel.

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