Mobile Medical Device Development
There is no doubt that the market is heading in the direction of mobile medical app design as new developing technology transforms smartphones and tablets into healthcare tools, bringing in a new era of digital health.
Bringing any medical device to market is a complex process and the relative newness of mobile medicine (mHealth) could add further complications. Mobile device technologies have unique challenges that need to be understood to assist in the design and development process. If your mobile device application needs to work on Android and iPhone devices, choosing to work with Sterling Medical Devices could make all the difference.
Experts in Mobile Medical Devices
- Full life cycle approach to medical device app design and development
- Experience in Android and iPhone mobile medical device projects
- Medical device app development for iPhone
- Medical device app development for Android
- Design medical device applications for iPads
- Mobile Medical Device Software/System verification and validation
- Algorithm Development
- Work on 510K, PMA and CE Class I, II and III devices resulting in successful submissions
- Get products to market quickly and cost efficiently
- Utilize state-of-the-art tools and electronic test equipment
- Completed independent verification/validation of medical systems to support your submissions
- Proven track record of FDA/CE approvals
Sterling is ISO 13485 registered and compliant with the following standards:
IEC 62304 – FDA recognized CE Mark requirement for medical device software development
ISO 14971 – Standard for medical device risk management
IEC 60601 – Series of technical safety and effectiveness benchmarks for medical electrical equipment
Maximizing efficiency through our mobile experience
Our team is highly experienced when it comes to working with the FDA and European regulatory bodies, and that experience includes mobile medical devices. Our engineering methodologies are optimized to keep expenses low and design times down. We know how to minimize the total duration of mobile medical device project to maximize your return on investment – all while keeping your bottom-line costs at a minimum. Plus, our reverse engineering service allows our clients to quickly create prototypes and utilize prior work to generate all the necessary documentation required for regulatory approval – all without compromising quality.
Whether you are just starting out or need help applying the finishing touches, it is never too late to get us involved.
Since our founding in 1998, Sterling Medical Devices has demonstrated expertise in delivering medical devices and related services that are aligned with customer and regulatory requirements. We help customers, ranging from startups to Fortune 500 corporations, in all facets of Class I, II, and III electronics medical device design by minimizing risks, overcoming time and budget obstacles, and maximizing chances of a successful FDA & EU approval process by doing things right the first time.
Free Project Analysis
Let Sterling Medical Devices show how to move your idea from concept to prototype to FDA/CE approval with a free customized analysis.