Quality Management & Regulatory Compliance

We provide quality management by establishing, maintaining or enhancing your quality systems according to ISO 13485, FDA 21 CFR part 820 Quality System Regulation and other relevant global QMS requirements.

Furthermore our solution consists of evaluating Quality processes and applying proven methodologies based on regulations to support you to implement best practices and meet computerized system validation (CSV) needs. 

The implementation of software as Medical Device is an essential and integrated part of our solution for our Medical Device customers.

Our solutions

your benefits

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Solution

  • Leading Quality Management/ GMP-projects to ensure regulatory compliance, with hands-on mentality (DIN ISO 9001 & ISO 13485) 

  • Conceptual improvement, optimization und harmonization of GxP- and quality relevant procedures for pharmaceutical or Medical  Device products 

  • Preparing Quality Management documents (SOPs & templates)

  • Document Management  

  • Planning and execution of trainings regarding guidelines (GMP, ICH, ISO-certification, GDP) in scope of national as well as international regulations   

Benefits

We ensure that your organization is equipped with a compliant Quality Management System according to ISO 13485 & ISO 9001. We provide you, if required, with all SOPs and templates, tailored to your needs.

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Find out more about our solutions, sucess stories and relevant topics.