REGULATORY, QUALITY AND COMPLIANCE

Buyer Aware, Not
Buyer Beware

Innovate responsibly across the spectrum of regulated solution classes and use cases.

Virtual Care, Digital Health, and Digital Medicine: from Wellness to Software-as-Medical-Device (SaMD) solutions, the evolution continues.  Whether planning for partners, data, product/service bundling or marketing – expert support is essential.  With Medullan, ensure your digital strategy, digital solution, and launch plans continue to meet compliance requirements.

Regulatory, Quality and Compliance Capabilities

  • Accessibility Compliance
  • Data Management, Residency & Privacy Compliance
  • Pre-SaMD & SaMD Transition
  • Program & Partner Governance
  • Medical, Legal, and Regulatory Risk Assessment
  • Accessibility Compliance

    Ensuring that all patients and consumers, regardless of physical, visual or auditory limitations have appropriate access to health information, solutions and applications in accordance with ADA or other legal mandates. 

  • Data Management, Residency & Privacy Compliance

    Planning for and addressing the risks and compliance involved in collecting, managing and storing health data.

  • Pre-SaMD & SaMD Transition

    Helping clients, with the assistance of Client and 3rd-Party SMEs, to prepare non-medical Digital Health Programs and roadmaps for future transition to support SaMD. While helping to facilitate DHF-Ready Ideation as inputs into the QMS/Design Control process.
  • Program & Partner Governance

    Coordination of internal stakeholders to tackle Digital Health GRC issues in an agile manner.

  • Medical, Legal, and Regulatory Risk Assessment

    Periodic and ongoing assessment and mitigation of all key risks, ensuring relevant compliance both for the innovation process and resulting solution(s) – from Customer Experience, to Ecosystem/ Business Models, to Journey Analytics.

 

Why Medullan?

Risk is smoke, not fire.  We commit to diligently addressing all forms of risk with a proactive, informed and integrated approach.

Interested in learning more?

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