QUALITY MANAGEMENT

Central to our success is the quality of our services. To meet the exceptionally high demands of our customers, all processes are monitored and optimized permanently. We follow the continuous improvement principle and regularly train our team.

Our high quality is certified according to ISO 13485:2016 and DIN EN ISO 9001:2015. All our services are conducted in alignment with GCP / GCLP, GCDP and GLP guidelines.

Success factors:

  • We demand the highest quality possible of our services
  • High customer satisfaction through flexibility and reliable implementation of requests
  • Continuous monitoring and optimization of all processes
  • Own quality assurance department
  • Regular functional training of all our employees regarding quality, occupational safety and environment protection

Quality milestones:

2022:

  • Surveillance Audit ISO 13485:2016
  • Surveillance Audit DIN EN ISO 9001:2015
  • GCP and GCLP qualified team (BSL2 Laboratory, Logistics, Study Monitoring, Project Management, QM, QS)

2021:

  • GCP RE-Qualification Audit for BVMA Membership with focus on ICH
  • GCP R2 Requirements related to the QM System
  • Surveillance Audit ISO 13485:2016
  • Surveillance Audit DIN EN ISO 9001:2015

2020:

  • Certification according to ISO 13485:2016
  • Surveillance Audit DIN EN ISO 9001:2015

2019:

  • Certification Audit Phase 1 ISO 13485:2016
  • Surveillance Audit DIN EN ISO 9001:2015

2018:

  • Certification according to DIN EN ISO 9001:2015
  • GCP-trained Team (S2 Laboratory, Logistics, Study Monitoring, Project Management, Quality Management, Quality Assurance)
  • GDP-qualified Team of Logistics

2017:

  • Certified member of BVMA (Federal Association of Contract Research Organisations)
  • GCLP-trained Team (S2 Laboratory, Logistics, Study Monitoring, Project Management, Quality Management, Quality Assurance)
  • GLP-qualification of quality manager

Our services are based on the following regulations and guidelines:

  • GCP / GCLP / GLP/ GDP
  • EU Medical Device Directive (93/42/EEC)
  • Directive on in vitro diagnostic medical devices (98/79/EC)
  • IVDR- and MDR-Regulations (Mai 2017)
  • DIN EN ISO 14155 – Clinical testing of medical devices
  • EN 13912 – Performance evaluation of in vitro diagnostics
  • ISO 20916 – In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
  • DIN EN ISO 23640 – In vitro diagnostic medical devices – Evaluation of stabiliy of in vitro diagnostic reagents
  • ISO 14971 – Medical devices – Application of risk management to medical devices
  • Clinical & Laboratory Standards Institute Guidelines (CLSI)