Medical Device Quality & Compliance
Sharing insights on medical device quality, regulatory, and project management
About Me
Quality Management & Regulatory Affairs
I have helped medical device companies implement quality systems that meet ISO 13485 and MDSAP standards, and successfully passed FDA 21 CFR Part 820 audits with zero non-conformities.
I have years of first-hand product registration and market approval experiences, with the successful deliverables Class I, Class II, and Class III approvals in of China, EU and the US.
Supply Chain Management
I optimize supply chains for medical devices, ensuring efficient import/export processes, strong supplier relationships, and smooth channel management for timely and high-quality deliveries.
Project Management
As a certified PMI Project Management Professional (PMP), I manage projects from development to market launch, ensuring on-time delivery and successful outcomes across all stages.
Join me on the journey; let’s help more people and businesses achieve growth and success!
15+
30+
3rd-Party Audits
Work experience
I am a seasoned professional with 15 years of experience in medical device industry, specializing in Quality Management, Regulatory Affairs, Supply Chain, and Project Management.
20+
MD Registration Certs
Certificates
I bring over 15 years managing quality, compliance, and supply chains in medical device projects, blending technical know-how with practical insights.
ISO 13485 Lead Auditor
Lead auditor for ISO 13485 QMS audits
Regulatory Affairs Certificate (RAC)
Regulatory Affairs Professional Society (RAPS) membership
Certified Manager of Quality/Org. Excellence
American Society for Quality (ASQ) membership and certified CMQ/OE
Supply Chain Professional
Self-trained Certified Supply Chain Professional (CSCP)
Data Analyst
Certified Data Analysis Professional
Quality Audit
Site or Supplier audits; FDA/NB on-site audit supporting. ISO 13485 certification/Product registration audit readiness and preparation.
Project Management
Lead cross-function, international product design and development projects with first-hand experiences and PMI certified PMP expertises.
Medical Device Registraion
Class I to III medical device registration with FDA, EU, NMPA; Registration strategy; Regulatory/QMS/Quality Tools training and consulting.
Supply Chain Consulting
Provide supply chain set up and enhancement insights for business decision-making. Instead of only high-level cliches, you will get value-stream-level points of view, feasible suggestions, as well as SC resources.
Expertise
Feedback
What clients say about mingyuefeng’s work
Mingyue has a strong sense of logical and structural thinking, which empowers her and makes her so adept at complex project management and carrying out.
Evan T.
Client
Mingyue has a strong sense of logical and structural thinking, which empowers her and makes her so adept at complex project management and carrying out.
Amy S.
Former Co-worker
