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We offer comprehensive consulting services for Medical Devices EU Registration, focusing on implementation and continuous improvement to ensure alignment with international standards. Our service encompasses strategic guidance and practical support to streamline the registration process and enhance compliance with regulatory requirements, enabling companies to navigate the complexities of European market access effectively
Our team collaborates with the client to develop a customized strategy for medical device registration in the European market. We define clear objectives, milestones, and action plans to guide the implementation process, establishing robust quality management and documentation practices to support regulatory requirements.
Our experts will implement mechanisms for ongoing monitoring, evaluation, and improvement of the registration process. Through periodic reviews and audits, we assess compliance status and identify opportunities for optimization.
Additionally, we provide training and support to empower internal teams in maintaining regulatory compliance and driving continuous improvement efforts.
We conduct a thorough assessment of the company’s existing regulatory practices and processes related to medical device registration. By doing this, we evaluate the alignment with relevant European regulations such as Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). By the end, the activities will identify GAPS and areas for improvement in regulatory compliance and documentation.
Digital Solutions (Computerized Systems) – Implementation and Improvements
Digital Solutions (Computerized Systems) – Routine Support
Qualification and Validation – Implementation and Improvement
Computerized Systems Validation Landscape – Implementation or Improvement
Master Data Management (Computerized Systems) – Strategic Consultancy
Access Management (Computerized Systems) – Strategic Consultancy
Implementation of a new Computerized System – Strategic Consultancy
Computerized Systems Validation Audit Readiness – Strategic Consultancy
Computerized Systems Validation Audit Readiness – Routine Support
Quality Management Systems Landscape – Implementation or Improvement
Quality Management Systems Audit Readiness – Strategic Consultancy
Water Systems Validation (WFI, PW and Pure Steam) – Strategic Consultancy
Water Systems Validation (WFI, PW and Pure Steam) – Routine Support
Computerized Systems Validation Landscape – Operational Documents Creation
Master Data Management (Computerized Systems)– Strategy Definition
Computerized Systems Implementation – Project Management with Quality Focus
Computerized Systems Validation Audit Readiness – Strategy Definition
Computerized Systems Validation Audit Readiness – GAP Assessment
Master Data Management (Computerized Systems) – Workshop and Trainings
Access Management (Computerized Systems) – Workshop and Trainings
Computerized Systems Validation Audit Readiness – CAPA Plan Management
Computerized Systems Validation Audit Readiness – Audit Execution
Computerized Systems Validation Audit Readiness – Workshop and Trainings
Quality Management Systems Landscape – Operational Documents Creation
Water Systems Validation (WFI, PW and Pure Steam) – Strategy Definition
Water Systems Validation (WFI, PW and Pure Steam) – Operational Documents Creation
Water Systems Validation (WFI, PW and Pure Steam) – GAP Assessment
Water Systems Validation (WFI, PW and Pure Steam) – Project Management
Water Systems Validation (WFI, PW and Pure Steam) – Workshop and Trainings
Medical Devices EU Registration – Implementation and Improvement
Nitrosamines: Compliance with requirements - Implementation and Improvement
Safe use of AI tools in Quality: Data Security and Process Optimization
Nitrosamines – Drug Substance Risk Management Strategy Creation (for NDSRI)
