Review and ensure compliance with industry standards.
SFDA, FDA, CE, UKCA, DRAP, IVDR.
Conduct literature search protocols. Analyze vigilance search data
Prepared for the safety of the material.
Monitor and report on post-market activities.
Implement systems in accordance with ISO 13485.
Assist in preparing and submitting regulatory documents.
Thoroughly review and ensure compliance.
Develop comprehensive risk management plans.
Evaluate regulatory compliance and identify gaps.
Develop effective regulatory strategies.
Tailored consulting services to meet specific needs.
