We analyze your business processes and offer support and concepts in all technical and quality-related areas in order to enable you a carefree work.
Why idcs gmbh?
To be successful and sustainable in today’s business world, you need to be able to focus on your core business.
Distractions and trivialities slow down your business processes and can be reasons for reduced competitiveness.
Our professional service company will help you to focus fully on your actual business.
what can we do for you
Creation of validation master plans, user requirements, performance specifications and technical specifications. Preparation and planning of all necessary documents for the validation of processes (design, installation, functional and performance qualifications) including supervision before, during and after implementation. Incorporation of the validation process into the existing quality management system. Interpretation of the validation according to requirements of EN ISO 13485 and the American regulation 21 CFR 820.
internal and external audits
Execution of internal or external process audits to verify compliance with the EN ISO 13485 standard or independent review of internal work processes and processes as specified by the client.
quality management systems
Establishment and development of internal or external processes for compliance with applicable regulations such as EN ISO 13485. Support in the development of QM systems and necessary documentation according to GDP (Good Documentation Practice) specifications.
CAPA (corective action and preventive action)
Creation, implementation, evaluation of corrective and preventive actions. Support in the introduction of a CAPA management system including integration into existing quality management systems.
Support in the preparation of risk assessments in accordance with EN ISO 14971. Development of risk management and incorporation into an existing quality management system.
General Technical Support
Implementation of projects with a technical background (for example, development projects, relocation of production, etc.) in various fields. Planning and organizing complex tasks. Compliance with goals and budgets as specified and agreed with the appropriate management.
Support in the design and implementation of various technologies in many areas of mechanical engineering (including the manufacture of medical instruments and implants). Experience in the metal working industry (casting, forming, machining, surface treatment, etc.).
construction and development
Support for development projects from start to finish. Design and variant construction (mainly 3D design), production drawings, design transfer to production.