Always by your side

We are with you every step of the way, from consultation at the start of the project through to secure approval from the Notified Body. Our specialists in quality management, quality assurance and regulatory affairs ensure that your product successfully meets all requirements from the outset and is approved for market entry.

Risk management at every phase

  • Preparation and review of the technical documentation
  • Feasibility tests accompanying the development
  • Product classification and identification of relevant standards
  • CE conformity
  • EMC testing
  • Product labelling and packaging review
  • Creation of the approval documentation
  • Preparation and review of documentation for international market approvals

QUALITY ASSURANCE & REGULATORY DOCUMENTATION

We are committed to continually enhance our processes and service quality to support you meeting regulatory and legal requirements in a constanty changing environment. We are certified according to EN ISO 9001 and DIN EN ISO 13485. For a complete list of all certifications click here.

DQS Certificate - ISO 9001 : 2015 Quality Management System - Certificate of ISO 9001:2015

PDF | 127.1 KB

DQS Certificate - ISO 14001:2015 Environmental Management System - Certificate of 14001:2015

PDF | 121.6 KB

IQNET Certificate - ISO 14001:2015 Environmental Management System

PDF | 497.2 KB

TÜV Zertifikat/Certificate - DIN EN ISO 13485:2021 / EN ISO 13485:2016+AC:2018+A11:2021 Development and design, production and distribution of devices and software for in-vitro diagnostic tests

DE/EN | PDF | 235.1 KB