Partners

 

Kees Frémery Advies & Training

Consultancy services for Medical Device sterilization & validation Advise, support and training in the field of:

• Microbiological sterilization validation, radiation and EtO
• Process validation, including validation protocols, writing Master Files
• ISO 11137, ISO11135 and supporting standards
• Maintaining process effectiveness
• Training of cleanroom Technicians
• Microbiological monitoring of cleanrooms and production locations

 

Allround 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.

 

Kader

Quality Assurance: certification consultancy & education.

 

 

 

Geeske van Oort

Clinical Reimbursement & Quality Consultant

 

 

 

 

 

VosFox Medical

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.