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About SQRC

Expert in Medical Device Quality and Regulatory Affairs

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.

Sophia Lam
CEO, Founder