About SQRC
Sophia Lam is the founder and senior consultant of SQRC.
I am a Quality & Regulatory Affairs professional with 29+ years’
experience in medical devices. This experience is acquired by
working for multiple organizations, varying in size from global
corporate organizations to start-up and scale-up companies.
I have extensive experience and demonstrated success in:
Quality Management Systems: Expertise in designing and implementing systems following ISO 13485, 21CFR820, and MDR standards.
Product Approvals: Successfully achieving approvals for medical devices across various classifications in both the US and EU markets.
Training and Coaching: Developing quality and regulatory specialists through comprehensive coaching and training.
Strategic Involvement: Actively participating in board meetings, investor sessions, and acquisition projects.
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