Nadira Salah, PhD
Quality Assurance Consultant
Nadira is part of the Quality Assurance team. With her B.Eng and MSc, she has gained a broad interdisciplinary knowledge in various fields of Biomedical Engineering, including medical Science, medical devices, software programming, tissue engineering and regenerative medicine. Besides her biomedical engineering background, she has good experience in designing, implementing, and executing various projects as well as training healthcare professionals.
Prior to Qserve, Nadira worked on her Ph.D. in Biomedical Engineering focusing on in vitro mucosa tissue models using functionalized electrospun biodegradable polymers. During her time at Qserve Group, she worked with several quality management systems and supported the implementation of ISO 13485:2016 and establishing technical documentation. Furthermore, she gained a good knowledge of the regulatory aspects of medical devices and in vitro diagnostic devices including the current MDD 93/42/EEC, MDR 201/745, and IVDR 2017/746.
Nadira has a bachelor's degree in Healthcare Technology Engineering from Aarhus University, Denmark, a master's degree in Biomedical Engineering from University of Strathclyde, UK and is getting her PhD in Biomedical Engineering from University of Glasgow, UK.
Expertise and competences:
• Establishing and implementing quality management systems according to ISO 13485 standards;
• Establishing QMS GAP analysis tool against the upcoming European Medical Device Regulation (MDR) 2017/745;
• Supporting with establishing technical documentation according to the MDD & MDR;
• Performing risk management using ISO 14971.
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