Saskia Schoenmakers, PhD

Saskia Schoenmakers, PhD

IVD Product Development
Senior Consultant 

Saskia joined the Qserve Group as a consultant in the growing IVD team and is based in The Netherlands.

Saskia about working at Qserve

I am passionate about using my experience and my pragmatic mindset to support manufacturers, distributors and users of IVDs providing safe and effective diagnostic tools to the global healthcare community. I am excited about working with and learning from Qserve’s experienced team of experts.

Before Qserve

Saskia has more than 15 years of experience in IVD product development, technical documentation and technical & application support. She has developed quality management systems compliant to ISO 9001, ISO 13485, and FDA 21 CFR 820 in order to meet requirements  of 98/79/EC(IVDD), 2017/746(IVDR), and US FDA.

Saskia has hands-on experience with several technology platforms using molecular and biochemical approaches, including development of companion diagnostics.

Prior to joining Qserve, Saskia was holding a role as Senior Inspector at the Dutch competent authority. She was responsible for market surveillance of IVD medical devices under Dutch and European legislations focusing on product safety, post-market surveillance and safe use of medical technology and was a member of the MDCG IVD working group.

Saskia holds a Ph.D. in medical sciences, more specifically in thrombosis and hemostasis, from the University of Amsterdam and a Master’s degree in medicinal chemistry from the Vrije Universiteit Amsterdam.

The key expertise areas of Saskia

  • Implementation and execution of IVD product development and life cycle management under ISO 13485:2016 and FDA 21 CFR 820
  • Quality Management Systems ISO 13485, ISO 9001, ISO15189
  • Application of ISO 14971 risk management including hazards analysis, design-, production- and use-FMEA, and risk mitigation
  • Competent authority inspections and follow-up at manufacturers, European authorized representatives, importers, distributors and laboratories using CE-marked IVDs and/or in-house developed devices
  • Documentation and review of design history files, device master records, and IVDD/IVDR technical files
  • Strong technical background in fields such as (cyto)genetics, (molecular) pathology, immunology, microbiology and clinical chemistry.
  • Translation of intended use and user needs into acceptance criteria and product design requirements
  •  Project Management skills, experienced in working with multidisciplinary cross-functional teams
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