White Paper

Future-Proof your Digital Health Regulatory Strategy

Key considerations for biopharma and medtech companies

Digital-savvy biopharma companies are adding new regulated digital health capabilities – such as controlling connected devices, drug dosing, decision support and automated interventions – as a way to improve patient engagement, deliver actionable insights to providers and provide more value around their products and therapies.

As you transition from developing simple companion apps, to capturing data from connected medical devices, to building Software as a Medical Device solutions, you need a compliant infrastructure and regulatory expertise to support your efforts. Building these capabilities within a biopharma or medtech company impacts your time to market, increases headcount costs and introduces additional regulatory and audit exposure.

This white paper explores the regulatory challenges associated with launching and maintaining a digital health therapy or medical device and provides recommendations on avoiding common – and often times costly – regulatory pitfalls. The white paper also explains the market need for a medical-grade IoT platform and managed service offering that goes beyond simple, non-regulated connectivity platforms.

Download this educational white paper today to:

  • Understand the limitations associated with medical device data systems (MDDS)
  • Learn how you can minimize risk while cutting costs by investing in a medical-grade IoT platform
  • Accelerate time-to-market of your biopharma and medtech products