Quality

genae has established, and maintains, an effective and efficient electronic Quality Management System (QMS). Our Quality Management System is ISO 9001 compliant and is continuously monitored to meet applicable statutory and regulatory requirements.

genae’s QMS comprises of a tracker which captures improvement suggestions proposed by quality staff, company personnel and third-party auditing teams. genae focuses on its customers and aims at exceeding customers’ expectations. Customer satisfaction is measured on a regular basis. In 2015, our Customer Satisfaction score was 93%.

Quality activities
Monitoring and measurement of processes:
  • Internal audits on genae processes
  • Management of process request improvement suggestions
  • Approved supplier/vendor management

Validation of e-tools:
  • Validation package for every product release
  • Creation of test scenarios and scripts to ensure quality of new and existing features
  • Assessment of industry-specific regulatory compliance guidelines and regulations

Quality Questionnaire
  • Client and investigational site evaluation of genae’s performance

Achievements
  • Quality achievements include successful audits
  • Vendor audits assessing genae’s processes
  • Investigational study audits performed by the client
  • National / regional Competent Authority and FDA audits at the investigational sites accompanied by genae

genae is on the Approved Supplier/Vendor List of the largest medical device companies worldwide.
I know I can trust genae because they understand the need for balance between what is feasible, what has to be done, and what is correct.
 

Prof. Marianne Brodmann

University Graz, Austria

Interested? Please contact us!

Ask the expert

Please submit your question