Quality
Gentian Health’s commitment to the medical device industry is demonstrated by its investment in both its Quality management systems as well as its Product regulatory and Compliance expertise.
Gentian Health is certified to the medical device standard ISO 13485 for both Design and Manufacture of electronic products
Medical Device Quality Assurance
Gentian Health’s in-house quality and regulatory team support the product development and manufacturing teams at every stage of the product development process.
The design and manufacturing process is wrapped in Gentian’s Quality system to ensure that a key output for our customers is a Documentation Set (Design history file) and technical file which meets both FDA and CE certification requirements.
ISO 13485 for design and manufacture of electronic and mechanical products.
FDA technical file management and submission. 510K and DeNovo.
CE certification and technical file management.
Gentian supports 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