About MediqWise Regulatory & Quality
Yu-Wen (Weny) is a seasoned Regulatory Affairs and Quality Assurance expert focusing on Software as Medical Devices (SaMD). With extensive expertise in navigating the regulatory landscapes of the US FDA, Health Canada, and international, she helps companies to excel at ensuring products align with international standards and regulatory requirements.
Passionate about fueling innovation, Yu-Wen specializes in aiding medical device startups to establish compliant and effective Quality Management Systems. She tailors her approach to meet each company’s unique needs, designing and implementing regulatory strategies that adhere to the required norms and foster growth and scalability.
Her experience extends to guiding software life cycle processes per IEC 62304. She also understands the risk management standards (ISO 14971) and usability (IEC 62366). Her skillset also includes providing guidance for cybersecurity practice and ensuring compliance for AI/ML-based, mobile-based, and/or cloud-based medical devices.
Skills and Expertise
- QMS Implementation (ISO 13485)
- Quality Plan and Continuous Improvement
- Post-Launched Quality Compliance
- Regulatory Project Coordination
- Training Design/Staff Development
- Risk Management (ISO 14971)
- IEC 62304
- IEC 62366-1
- IEC 60601-1
- Regulatory knowledge of medical devices, in vitro diagnostic devices, and medical device software (SaMD/MDSW) for EU, US FDA, Health Canada, Australia TGA, Brazil ANVISA, Colombia INVIMA, Taiwan TFDA, and other jurisdictions.
Publication and Presentation
- Contributed author of
- Regulatory Affairs Professionals Society (RAPS), From X-Rays to AI: Navigating US Regulations in Radiological Health. ISBN: 978-1-947493-90-2
- Invited Speaker
- McGill University, BMDE-654-001 - Biomed Reg Affairs-Med Devices, on SaMD, cybersecurity, and AI-based medical devices, 2021, 2022, 2023.
- Medtech Canada, Intro to Regulatory Affairs in Software as Medical Devices (SaMD), Dec 15, 2022.