I have partnerships with other independent experts, all Consultants in their own field of expertise.
Together we can offer a complete package of needs.
Q-team is a group of partners who can advise in all kind of projects with more fields of expertise. Partners in this team are:
- Lydia Kluver (Quality Made Easy)
- Henri Willems (Medical Device Service Netherlands)
- Erik-Jan de Jong (All Round Technologies)
- Christophe Janssen (Kader)
- Yorick van Eijndhoven (Kader)
- Geeske van Oort
- Sandra de Vos (Vosfox Medical)
- Frank van der Zanden (Sure Laboratories)
- Kees Fremery (Kees Fremery Advies & Training)
Quality Made Easy
Quality Made Easy was founded by Lydia Kluver in 2010. After more than 30 years of experience, working for several employers, she decided to set up a company of her own.
QME can assist you, as a subcontractor or manufacturer of (IVD) Medical Devices, with the planning, implementation and maintenance of your EN ISO 13485 Quality Management System.
Medical Device Service Netherlands
Henri Willems is an expert in Packaging Validation, Technical Files and Audits
All Round Technology
AllRound Technology has an extensive experience in developing and certifying medical devices according to the stringent European standards that are acknowledged globally. We are deeply committed to serving professionals in the medical industry to get their products to market, and ultimately helping patients.
We help our customers developing a consistent and effective quality management system, technical file, Intended use, interpretation of standards and regulations, formal risk analysis, and a retention system for certain critical documentation.
Geeske van Oort
Geeske van Oort is Clinical, Reimbursement & Quality expert. Geeske holds a Master’s degree in Physics (University Twente). She has worked for over 30 years in the medical device industry (Medtronic, Vitatron, St Jude Medical, The eNose Company) from early research to market access.
- Clinical evidence, Quality, Market access, Reimbursement issues, Health Economics
- Development of Clinical plan, definition of objectives, Study design
- Evaluation of clinical data to verify the safety and performance of medical devices according to Meddev 2.7/1 rev. 4
- Post market surveillance
Vosfox Medical offers contract manufacturing services and consulting services for the medical device market. We are specialized in Medical 3D printing. We have several printers in a class 7 cleanroom and we provide medical grade filament for 3D printing. However, start-up companies, specialized in their own technology can also use our facilities and services.
Besides QA/RA services for customers using our facilities we also offer all other customers support. We are specialized in Class III (resorbable) medical devices, polymer devices, and biocompatibility.
Sure Laboratories is your go-to service-laboratory and provides you:
- Routine analyses for Medical Devices, Personal Care products and Pharmaceuticals
- Validation, qualification of products and processes
- Suitability testing of microbiological methods
- Project based research in favor of R&D projects such as development and optimization of new sterilization and disinfection methods
- Microbiological monitoring of clean rooms.
Quality Assurance: certification consultancy & education.
SteriComp GmbH is a German Consultancy agency with two experts in QMS and EtO sterilization.
- Manuel Grandy
- Ümit Cakirgöz