Quality Assurance Expert
Nadira joined Qserve Group in 2017. With her MSc and PhD she has 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 experience in the execution of
During her time at Qserve Group she worked on quality management systems, implementation of ISO 13485:2016, MDSAP, experience with global registrations of medical devices and establishing and reviewing technical documentation of various medical devices according.
Furthermore, she has worked on projects involving the implementation of European Medical Device Regulation (MDR) 2017/745. Besides working with regulatory and quality related projects, Nadira joined Qserve CRO as Clinical Research Associate (CRA) and is involved in various CRO activities. She has also experience with the biological safety evaluation of medical devices according to the ISO 10993 series.
The key expertise areas of Nadira include:
- Regulatory, quality, and clinical support to medical device manufacturers
- Establishing and implementing quality management systems according to ISO 13485 standards
- Establishing and implementing MDSAP compliant quality management systems
- MDSAP & ISO 13485 auditing
- Experience with complaint and CAPA management
- Establishing GAP analysis tool against the upcoming European Medical Device Regulation (MDR) 2017/745
- Advice on the interpretation of the MDD, MDR and other legislation (FDA 21 CFR, Canada MDR, TGA, etc.) pertaining to medical devices (such as regulatory pathways, classification, etc.)
- Experience with Post-Market activities
- Scientific review and Clinical evaluation
- Clinical site assessment, qualification, and selection
- Monitoring at (international) sites
- Good clinical practice (GCP)
- Good Manufacturing Practice (GMP)
- Supporting with establishing technical documentation according to the MDD and MDR
- Supporting with global medical device registrations and establishing submission dossiers
- Performing risk management using ISO 14971
- Biological safety assessment of medical devices - ISO 10993 series
Nadira about working at Qserve
"What I really enjoy is being a part of this team. I know that we have a positive influence on the work that we do. I have the freedom to fully develop myself in specific areas that are of interest to me. Qserve is a company that is really growing, and it is very motivating to be a part of that growth!"
Prior to Qserve, she was working on her PhD in Biomedical Engineering focusing on in vitro
mucosa tissue models using functionalized electrospun biodegradable polymers.
Besides her PhD, Nadira has experience a Technical Software Consultant where she was responsible for the implementation of patient logistics software solutions in hospitals throughout Denmark.
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