Rania Gerges, MSc

QMS & Statistics Expert

Quality Assurance Consultant

Rania brings to Qserve more than 12 years of experience in product development, quality engineering, and quality management system development. Besides that, Rania does Gap assessments against the MDR (QMS, Clinical Evaluation Report and Technical Files), implementation of PMS and PMCF requirements, Remediation of companies' QMS against ISO and the MDR. Rania also gives training on the QMS aspects of the MDR/IVDR. 

The key expertise areas of Rania

  • MDR
  • Auditing
  • Training
  • Remediation and building QMS for startup and small companies
  • PMS
  • Risk Management
  • Design controls

Rania about working at Qserve

“I am honored to be part of a global medical device consultancy team highly skilled in the field of regulatory affairs and compliance, quality management system, auditing, clinical affairs and training. I am excited about this rewarding career journey, in which I contribute to Qserve’s mission to help improve patient safety and health through supporting the advancement of medical devices companies. This move will not only sharpen my current skills, but it gives me an opportunity to develop new ones in the innovative field of medical devices.”

Before Qserve

Rania started at DEKRA Notified Body where she developed strong foundations in EU regulations, CE technical file assessments and auditing to ISO 13485 and the EU-MDD. This shaped Rania’s career into Quality Engineer positions, in which she developed a passion for quality while always integrating the underlying regulations for the everyday tasks. Rania did not separate the field of quality from regulatory and that makes her an exceptional and go-to engineer in both Integra Lifesciences and Zimmer Biomet for product development, quality engineering and regulatory guidance. 

Rania has a bachelor’s degree in Biomedical Engineering from Drexel University and a master’s degree in Applied Statistics from Rochester Institute of Technology. Rania is a Certified Quality Engineer by the American Society of Quality and she is a Certified ISO 13485:2016 Lead Auditor.   

Learn more about our services within Quality Assurance

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