Compliance & Standards
Medical Devices & Diagnostics
Quality systems, risk management, market authorization, and post-market compliance for medical devices and IVDs.
Regulatory landscape
Standards and frameworks in this category
Each topic links to an existing Viltis service page describing implementation, assessment, and remediation support.
FDA QMSR & ISO 13485
QMS readiness, harmonization, and certification-body audit preparation.
MDSAP Audit Readiness
Mock audits, jurisdiction-specific prep, and remediation support.
ISO 14971 Risk Management
Lifecycle risk management, hazard analysis, and benefit-risk documentation.
Design Controls & DHF
Design control systems and design history file remediation.
EU MDR
Technical documentation, clinical evaluation, and CE marking support.
EU IVDR
Performance evaluation and IVD conformity assessment support.
510(k), De Novo & PMA
FDA medical device submission pathway strategy and documentation.
IEC 62304 & SaMD
Medical device software lifecycle and digital health compliance.
Medical Device Cybersecurity
Premarket and postmarket cybersecurity documentation and design support.
Related engagement
Biologics CMC Analytical Dev. Consultant
Phase III biologics analytical development support with LCMS expertise and new CRO relationships.
Discuss medical devices & diagnostics compliance
Share your current controls, upcoming audits, or remediation priorities.