About MediqWise Regulatory & Quality

Practical regulatory monitoring and RA/QA support for early-stage medical device companies

About MediqWise Regulatory & Quality

MediqWise Regulatory & Quality is a regulatory affairs and quality assurance consulting practice based in Burnaby, British Columbia, Canada.

MediqWise supports medical device, SaMD, IVD, and digital health companies with regulatory standards monitoring, regulatory affairs support, and QMS support. The service is especially suited to startups and early-stage companies that need practical, fit-for-purpose regulatory and quality support without creating unnecessary complexity too early.

MediqWise helps clients establish regulatory and quality processes that meet them where they are: practical for today’s needs, expandable for future growth, and aligned with future regulatory and quality system expectations.

About Yu-Wen (Weny)

Yu-Wen Wang, PhD, is a regulatory affairs and quality assurance professional with practical experience supporting medical device, in-vitro diagnostic, SaMD, and AI/ML-enabled medical device development.

Her work focuses on applying regulatory and quality management system thinking early in product development, so that emerging devices are developed with their intended use, validation needs, clinical context, and future design-control expectations in mind.

Selected Publications and Professional Contributions

  • Contributing author, “Diagnostic X-Ray Imaging,” in From X-Rays to AI: Navigating US Regulations in Radiological Health, Regulatory Affairs Professionals Society, 2023.

  • Contributing author, “Diagnostic Ultrasound Systems,” in From X-Rays to AI: Navigating US Regulations in Radiological Health, Regulatory Affairs Professionals Society, 2023.

  • Contributing author, “Cybersecurity of Medical Devices,” in Fundamentals of Medical Device Regulations: A Global Perspective, Regulatory Affairs Professionals Society, 2025.

  • Invited speaker, McGill University, BMDE-654 Biomed Reg Affairs - Medical Devices, on SaMD, cybersecurity, and AI-based medical devices, Since 2021 - 2025.

  • Speaker, Medtech Canada, Intro to Regulatory Affairs in Software as Medical Devices (SaMD), Dec 15, 2022.