Li-Med
Eurofins Li-Med supports Medical Device startups and established companies in achieving their regulatory and QA business goals by helping them navigate through the challenging and changing regulatory maze, pass the most rigorous inspections, and bring products to approved status.
Industries
Nr. of Employees
small (1-50)
Services
Consulting to plan and prepare regulatory submissions for target markets (US FDA, EU CE/MDR/IVDR, China NMPA).
Design and implementation of QMS aligned to ISO 13485 and FDA QSR, including gap analysis, procedures, and documentation support.
Preparatory internal audits, ISO 13485 audits, and ISO 27001 audits to evaluate compliance and prepare for external assessments.
Support for IEC 62304 software lifecycle compliance, ISO 27001 alignment, and HIPAA-related privacy controls for software and AI medical devices.
Guidance and coordination of sterilization validation and biocompatibility testing to support safety claims and regulatory submissions.
Preparation for conformity assessments, technical file assembly, and support during Notified Body audits.
Consulting to plan and prepare regulatory submissions for target markets (US FDA, EU CE/MDR/IVDR, China NMPA).
Design and implementation of QMS aligned to ISO 13485 and FDA QSR, including gap analysis, procedures, and documentation support.
Preparatory internal audits, ISO 13485 audits, and ISO 27001 audits to evaluate compliance and prepare for external assessments.
Support for IEC 62304 software lifecycle compliance, ISO 27001 alignment, and HIPAA-related privacy controls for software and AI medical devices.
Guidance and coordination of sterilization validation and biocompatibility testing to support safety claims and regulatory submissions.
Preparation for conformity assessments, technical file assembly, and support during Notified Body audits.
Expertise Areas
- Regulatory compliance and strategy for medical devices
- Quality management systems (ISO 13485, FDA QSR)
- Medical device software compliance and cybersecurity
- Sterilization validation and biocompatibility testing
Key Technologies
- ISO 13485 QMS implementation
- FDA 21 CFR Part 820 (QSR) processes
- IEC 62304 software lifecycle processes
- ISO 27001 information security management