Biblioteca de información de productos médicos y productos combinados

Para proporcionarle información hemos compilado una amplia biblioteca de artículos, fichas técnicas y noticias relacionadas con los productos sanitarios. Llámenos (o envíenos un mensaje por correo electrónico) si necesita asistencia adicional o tiene alguna pregunta que no esté cubierta aquí. Estaremos encantados de ayudarle.

Folletos

• Our Promise To You
• Excellence in Medical Device Testing
• Excellence in Medical Packaging Testing
• Electronic Cigarette Testing
• Human Factors Testing
• Global Excellence in Medical Device Material Testing
• MET ISO-11040-8 and ISO-11608 Prefilled Syringes
• Selecting a Medical Device Testing Laboratory

Descripciones de servicio

• Comparison of ASTM and ISTA Transit Simulation Methods
• Comparison of Transit Test Regimes ASTM D 4169 versus ISTA 3A
• DVT for pre-filled syringes
• Endovascular Testing Services
• Exractables And Leachables Flow Chart
• Customer Returns and Post Market Surveillance
• Packaging System Validation Shipping
• Sterile Barrier Validation Shelf Life
• Validation of Packaging Equipment
• Extractables and Leachables Analysis For Injection Devices
• Guidance on the Application of ISO 10993:2018

Asesoramiento técnico

• Apply FDA Guidance On Product and Package Stability Studies
• ISO 18562 − Biocompatibility evaluation of breathing gas pathways in healthcare applications
• Verification of Injectables in Transport and Storage
• Endovascular Device Testing
• Force Testing in Medical Devices
• Leak Test Multi Lumen Catheters
• Leak Test Sealed Packages
• Material Characterisation
• Medical Device Leak Test Guide
• Medical Device Biocompatibility Testing
• Medical Device Micro Engineering
• Selecting a Medical Device Testing Laboratory
• Select a Sterilisation Process
• Test Bags and Flexible Products
• Validate a Medical Device Packaging Process
• Validate Shelf Life Claims
• Transport Testing Regimes
• ISO 11608   Injection Systems Flow Chart
• MET-ISO-11040-8-Prefilled-Syringes-Italian

Certificaciones

• Accreditation Certificate