Quality and Regulatory Affairs

Lumos employs a qualified in-house quality and regulatory affairs team with experience in global IVD/Medical Device test development and planning, strategy, submissions, and quality management systems in accordance with international standards and good manufacturing practices (GMP)

Core competencies include:

  • Global regulatory strategy
  • Global regulatory submissions
  • Technical documentation EU MDD/MDR; IVDD/IVDR
  • Regulatory and cultural intelligence
  • Risk Management
  • Agency meeting packages and participation
  • CMMI and MDDAP
  • Quality Management Systems
  • Quality Management Representative and Persons Responsible for Regulatory Compliance
  • Regulatory and Quality expertise for cross-functional teams
  • Regulatory and Quality gap assessments for commercial and lab-developed tests
  • Labeling and Promotional material review
  • Post-Market Surveillance

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