Designing products for the Healthcare industry is completely different from designing products for any other industry.
We envision every possible scenario with your product (or idea) that may result in fatal errors during the design phase.
We plug such loopholes in the design to prevent product recalls that become very expensive for a company.
(For those products that fall into the bracket of Software-as-a-Medical-Device or Digital Therapeutics)
Our know-how of design controls (ISO 13485/ 21 CFR 820.30) will ensure that your products are designed in compliance with required quality standards.
The opportunities presented by IoT – enabled medical devices, wearables, tele-medicine, and AI are immense.
But they come together with the challenges of information security, system interoperability and increased regulatory oversight.
With our expertise in the FDA MDDS (Medical Device Data Systems) and HIPAA we will help you identify potential regulatory barriers at an early stage,
while our experience with the HL7 will help you integrate your solution with Health Information Exchanges.
Together, we will ensure that your customer’s needs remain in focus while we make your solution more personalized and precise.
Data is impersonal. It is often siloed, often leading to reduced value.
Transforming siloed data into organized data sets and services for clinical and public health research rapidly increases its value.
We help organize data in a way it facilitates rapid design and development of predictive and early warning systems.