Eva Chang

At GSD, Eva supports clients with:

US submissions: PMA, IDE, 510(k) and Q-Submission strategy and authoring, including negotiating evidence requirements with FDA and responding to deficiencies.

EU MDR and international markets: MDR gap assessments, technical documentation and labeling remediation, Notified Body engagement, and market entry across Asia-Pacific, Latin America and EMEA.

Regulatory strategy and lifecycle management: regulatory roadmaps for development pipelines, change assessments and global notifications, and regulatory due diligence for financing and M&A.

Quality systems and audits: QMS management, ISO 13485 audits, CAPA, complaint handling, vigilance and post-market surveillance.

Background: Before joining GSD, Eva led regulatory affairs at Atia Vision, where she secured IDE approval for a novel Class III implantable intraocular lens; at ReShape Lifesciences, where she obtained PMA supplement approvals for implantable gastric banding systems and served as co-PRRC; and at AcuFocus (a Bausch + Lomb company), where she authored the original PMA for a first-in-class implantable intraocular lens. Earlier, she spent 16 years at The HydraFacial Company, rising to Head of Regulatory Affairs and serving as Management Representative. Her work spans ophthalmic, cardiovascular, respiratory, gastrointestinal, neurostimulation and aesthetic devices. Eva holds a Master's degree from Emerson College, the RAC-US and RAC-Devices credentials from RAPS, ISO 13485:2016 Lead Auditor certification and the ASQ Certified Biomedical Auditor certification, and has served on the board of the Orange County Regulatory Affairs Discussion Group.