Duan Threats has been in the industry for 19 years, primarily focused on In Vitro Diagnostic (IVD) devices. He has experience supporting the regulatory compliance and labelling needs of IVD devices such as molecular diagnostics (MDx), companion diagnostics (CDx), hematology analyzers, urinalysis, flow cytometry and hemostasis in Europe, United States and other markets around the world. Duan has been with NAMSA since 2020 and has previous work experience at Sysmex, Abbott Molecular and MABIS DMI Healthcare.
CORE COMPETENCIES
- Compliance with FDA, Canada and Latin America regulations, listings and licenses and applicable international regulations
- FDA Regulatory Submissions
- Creation of regulatory assessments for design change/change control, filing and or updating Unique Device Identification (UDI) records
- Creating, revising and reviewing labels in compliance with US and International Regulations
- Certificates to Foreign Government (CFG)
- Ensuring labels are compliant with Globally Harmonized Systems (GHS), BS ISO 9001, ISO 13485 symbolization codes and supporting global registrations
- EU IVD Directive and IVD Regulatory Support and gap assessments
RECENT PROJECTS
- Regulatory change control assessments for post-market IVD devices
- Laboratory Developed Test (LDT) regulatory assessment
- Survey labeling & registration requirements of Asia-Pacific regional countries