Quality management systems for medical devices

standpunkt: 

Quality always means full personal activity.

In addition to the product related requirements  for medical products you have to meet  several organization-standards by law, for example risk management,  a monitoring-system and certain medical device reporting requirements.
Quality management systems include all areas of a company in order to guarantee  the highest quality and safety standards of the product.

Your advantages:

Our quality management systems cover both the requirements of the EU and those of the FDA in the United States.
We use the benefits of a comprehensive quality management system in order to give you an ideal management tool.
You give us your corporate goal,  we develop the data base and criteria enabling  you to check, evaluate and adjust your goals. If necessary these data will also help you implement preventive measures. 

Our Services

  • Quality management systems in accordance with European Directive 93/42/EEC, ISO 9001/2000, special requirements for medical devices in accordance with ISO 13485 and in accordance with the guidelines pursuant to US-Good Manufacturing Practices (GMP) / Quality System (QS) Regulations.
  • Accreditation of medical laboratories in accordance with ISO 17025 in the ZLG
  • Risk management system in accordance with ISO 14971
  • Monitoring and performing of preparation, certification and internal audits
  • Independent quality management consultant (QMB)
  • Training of employees for the tasks of medical products consultant and security representative for medical products.

Market

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Technics

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Finance

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