Cheryl Fisher - Senior Consultant, Quality Assurance

In her role with Emergo, Cheryl is responsible for implementing and auditing FDA QSR and ISO 13485 compliant quality systems for medical device and IVD companies. She has extensive experience designing robust quality management systems that withstand regulatory inspections and regularly performs employee training on CE Marking, ISO 13485, FDA GMP and internal auditing.

Prior to joining Emergo, Cheryl spent several years with Boston Scientific/Guidant. In this capacity, she performed many ISO 13485 and FDA GMP audits, collaborated with auditees to develop corrective actions, communicated audit results to senior management and trained personnel on device regulations. Cheryl has also worked as a contract auditor for TUV Rheinland, giving her a unique perspective on how device companies should maintain compliance with regulations and standards.