Medical Device Consultancy
Services in this category ▼
Consultancy
Sistem Patent Kalite offers 14 services under Medical Device Consultancy. Contact our team to find the right fit for your organization.
UTS (Product Tracking System) Consultancy
UTS Product Tracking System consultancy for manufacturers, distributors, and logistics operators. Sistem Patent Kalite covers setup, training, and management.
National Database (UBB) Registration Services and Consultancy
National Database (UBB) registration for medical products in Turkey. Sistem Patent Kalite handles preparation, filing, and ongoing updates.
Medical Devices Directive: Product Safety and Quality
The Medical Devices Directive sets the requirements for device safety and quality. Sistem Patent Kalite supports certification and market access.
Medical Device Software Validation
Medical device software validation: confirming reliability, accuracy, and performance for software used in medical devices.
Medical Vigilance (Medical Vigilans)
Medical vigilance service: monitoring, evaluating, and reporting adverse events for medical products across the post-market life cycle.
Medical Product Labelling Services and Consultancy
Medical product labelling services and consultancy: design, regulatory alignment, and production of labels for medical devices and pharmaceuticals.
Medical Sterilisation and Validation Services
Medical sterilisation and validation services: method selection, protocol design, and certification for hospitals, clinics, and manufacturers.
Good Distribution Practices (GDP) Certificate for Medical Devices
GDP (Good Distribution Practices) certification for medical devices covers quality, safety, and effectiveness across the distribution chain.
Certification for In Vitro Diagnostic Medical Devices under EU 2017/746
In Vitro Diagnostic Medical Devices certification under EU Regulation 2017/746 (IVDR). Sistem Patent Kalite manages the certification workflow.
Biocompatibility Testing and Certification
Biocompatibility testing and certification for medical devices, pharmaceuticals, and cosmetics. Sistem Patent Kalite manages the process.
Regulation on Active Implantable Medical Devices
Active Implantable Medical Devices regulation: design, production, distribution, and certification with Sistem Patent Kalite.
93/42/EEC Medical Devices Directive Certification
93/42/EEC Medical Devices Directive certification and CE marking for EU market access. Sistem Patent Kalite manages the certification workflow.
90/385/EEC Aktif Yerleştirilebilir Medikal Cihazlar Belgelendirme
90/385/EEC Aktif Yerleştirilebilir Medikal Cihazlar Belgelendirme
90/385/EEC Active Implantable Medical Devices Certification
90/385/EEC Active Implantable Medical Devices Directive certification and CE marking. Sistem Patent Kalite guides manufacturers through the EU route.
