IDCS GmbH

MedTech (medical device)

Validation / Qualification
Implementation of Master Validation Plans, Essential Requirements lists, Requirement and Performance Specifications. Implementation and Planning of all necessary documents for Validation of Processes (Design-, Installation-, Operational- and Performance Qualification) including assistance on-site, during and after the implementation. Integration of validation processes into existing Qualtity Management Systems. Validation execution according valid standards EN ISO 13485 and 21 CFR 820.

Internal and external Audits
Execution of internal and external process audits for verification of compliance with EN ISO 13485 or independent inspection of internal operating procedures.

Quality Management Systems
Implementation and development of internal or external processes for compliance with EN ISO 13485 or similar standards. Support in implementation and necessary documentation according GDP regulations (Good Documentation Practise).

CAPA (Corrective Action and Preventive Action)
Implementation, Execution, Evaluation of Corrective Actions and Preventive Actions. Support in implementation of CAPA Systems inklusive integration to existing Quality Management System.

Risk Management
Support in risk assessment according EN ISO 14971. Implementation of risk management and integration in existing Quality Management System.

General Technical Support

Project Management
Execution of projects with technical background (e.g. development projects, outsourcing, etc.) in various areas. Planning and organisation of complex challenges. Compliance of goals and budgets according regulations from management.

Company’s Keywords:

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