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510(k) Submissions | QMS Architecture | ISO 13485 | eQMS | CSA
QARA consultant with five years in Class II medical device regulatory and quality systems, currently Head of QARA at a US-headquartered device manufacturer. Led an FDA 510(k) clearance (K243371) for a Class II Automated Peritoneal Dialysis system, built a QMS from zero to ISO 13485 certification in under three months, and architected an eQMS validated to 21 CFR Part 11 and CSA. Beyond my primary role, I take on independent engagements in third-party ISO 13485 audits, AI-driven compliance platform development, GxP/CSA training design, and technical documentation, primarily for US-based clients and consultancies.
EU MDR
US FDA
Regulatory activities
Device characteristics
Where they can act
Faizan Javed is a regulatory-affairs lead in the medical device industry. They also work in QA Manager, QARA Manager. Based in Pakistan. Explore their full professional profile and affiliations on MD Atlas.