REGULATORY, QUALITY AND COMPLIANCEBuyer Aware, Not
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
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 TransitionHelping 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.
Risk is smoke, not fire. We commit to diligently addressing all forms of risk with a proactive, informed and integrated approach.