Ineke van den Brink

My working area is in the field of medical device and biotechnology regulation and standardization.

I can fulfill various functions, like e.g. QA/RA manager, Project manager/Expert member in D&D projects, Validation engineer, Auditor, and Facility manager.

As project manager at a university research institute, I was involved in development of an innovative medical imaging research center and part of the construction team, focusing on e.g. floor planning, logistics, installation and finance. I was also responsible for setting up and qualification of laboratories and facility management.

I have worked as project manager, senior developer and trainer in a tissue engineering company under GLP and GMP conditions, involved in setting up laboratories, a clean room, QA systems and responsible for specific Design History Files and equipment qualifications and validations.

Before that I worked in a biological safety testing facility. I started in a university hospital working on tissue engineering and biomaterial-tissue interactions, using cell culture techniques, biochemical assays, animal testing, histological and electron microscopical evaluation techniques.

My fields of expertise are in:

– Project management design and development of medical devices
– Building, utility & clean room validations
– Laboratory, clean room and medical facilities installations
– Facility management focused on laboratories
– Equipment qualifications and validations (e.g. production, packaging, shelf-life)
– Set up/write/maintain design history files, technical dossiers, 510(k) dossiers and Master Files
– Set up quality management systems (ISO 13485 / ISO 9001)
– Internal/supplier auditing
– Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP)