Luana Zerafa

Luana
Zerafa

Senior Consultant, Quality and Regulatory Affairs


Luana Zerafa has over 12 years of industry experience, working with medical devices and applicable regulations in all classes, including implantable devices, ophthalmic products, and medication delivery products. Luana is specialized in Quality Engineering and has extensive knowledge on Quality System implementation and improvement as well as compliance to many international standards. She has deep experience in complaint handling and vigilance primarily in the EU; application of lean Six Sigma methodology to make processes more efficient; leading audits; training peers on quality/regulatory topics and dealing with Regulators and Notified Bodies in audit situations as well as FSCAs. As Senior Consultant at Emergo by UL, Luana consults on various Quality and Regulatory Affairs projects, including MDR gap assessments and audits, MDR training, and Clinical Evaluation Report compilation.