Regulatory consulting for telehealth and mobile apps
Is my iPhone/iPad/Android app considered a medical device? Is my smartphone app considered a standalone product, component or accessory to a medical device? Are there FDA, EU, or other country regulations which apply to me as a software mobile app developer? At Emergo, we hear these questions often and we can assist you in addressing these and other critical mHealth development issues.
Mobile Health/Telehealth/eHealth consulting services we provide:
- Regulatory assessments for medical iPhone/smartphone apps during pre/early-product development
- FDA and EU classification consulting and regulatory strategy
- US FDA Medical Device Data Systems (MDDS) compliance
- Design control consulting for compliance with US FDA Quality System Regulation 21 CFR Part 820, ISO 13485:2003 and EU Medical Devices Directive
- Medical device software validation consulting
- IEC 60601, IEC 62304, R&TTE Directive and C-tick compliance
- Marketing promotion/claims review for your smartphone app
- Medical device registration with the US FDA, Europe or other countries
Experienced software and medical technology regulatory consultants
Emergo has experience working with medical device manufacturers who make a wide variety of patient monitoring, disease management, PACS imaging and other software-containing medical devices whose value and effectiveness can be enhanced through mHealth technology.
Whether you are developing a remote monitoring component to your existing medical device, or a standalone diagnostic tool to be delivered via iPad, iPhone or another smartphone platform, we can help you conduct an assessment of your regulatory responsibilities with the FDA and other regulatory bodies worldwide. Also, read our page on how to determine whether your mobile app is a medical device. Our team can assist in preparing and submitting your mobile app to obtain US FDA 510(k) clearance or CE Marking approval in Europe.