Robert van Boxtel
I am a senior consultant in the medical device regulation with a vast experience in EU and USA regulations.
After 8 years in the medical device industry in R&D and manufacturing, I worked more than 7 years at Notified Body KEMA Quality / DEKRA. As Sr. Project manager and account manager I was responsible for quality system audits and dossier reviews under EU Medical Device regulations. Additionally, as product expert FDA 510(k) 3rd party accreditation program, I was responsible for the internal review process and performed file reviews myself, including contacts with the FDA. Over the years, my client database developed to include large accounts and small startup companies in the technology hotspots in the world (USA, Israel, EU). Specific focus on drug-device combination products, including the required consultation procedures with the drug authorities.
My fields of expertise are in:
– Project management design and development of medical devices
– Building, utility & clean room validations
– 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)
– Cardiovascular / orthopedic / ophthalmology / wound dressing experiences, with a focus on borderline products (drug-device, cosmetics, disinfectants).