At Gentian Services, we recognize Quality as key to customer satisfaction. Because of this Gentian has invested heavily in developing both its Quality Management Systems as well as its Product Regulatory and Compliance expertise.

Along with the standard ISO 9001 certification, Gentian is certified to the medical device standard ISO 13485 for both development and manufacture of electronic products.

Gentian has also managed the 510K submission process for FDA regulated products on behalf of some of its customers and as a result is expected to be an FDA registered site by Q4 2019.

Regulatory and Compliance certification

  • ISO 9001 for design and manufacture of electronic and mechanical products.
  • ISO 13485 for development and manufacture of electronic and mechanical products.
  • ISO 13485 for manufacturing of both mechanical and electronic assemblies.
  • 510K file management and submission.
  • CE certification and technical file management.
  • FDA registered site for a product we have developed for one of our clients. 510K submitted and registration pending.

Product Certification

  • Gentian manages the compliance process from design concept to attainment of appropriate certification.
  • Gentian products are designed for compliance with specified standards from the appropriate regulatory bodies.
  • Gentian has a proven track record of designing for and attaining the following certifications across a range of products and projects:
    • CE and multiple other territory certifications.
    • FCC.
    • FDA.
    • UL.

By working with Gentian we have been able to control costs during the design phase of our new projects as well as reducing our overall time to market. Gentians ability to understand the fluid nature of our industry’s environment and react and manage accordingly has been critical to the success of our projects.

- Marcus Creaven. MD AGC instruments.

Sectors we work with

  • Handheld Electronic Devices
  • Analytical Instrumentation
  • Electronic Products for the Medical Sector

Irish Office:
Gentian Services LTD
Unit 89.3,
Shannon Freezone West,
Shannon , Co Clare
T: +353 61 704 986