Quality Assurance

In order to bring products to the market, it is mandatory for medical device manufacturers to have a Quality Management System (QMS) in place. We can help you achieve this by supporting you with the creation of your QMS based on the ISO13485 or ensure the maintenance.

Quality Management System (QMS)

genae has established, and maintains, an effective and efficient Quality Management System (QMS). Our QMS is ISO 9001 compliant and is continuously monitored to meet applicable statutory and regulatory requirements. genae's QMS is regularly audited by its customers and regulatory bodies.

genae's Digital Health business unit is ISO27001:2017 certified for all its software development and database solutions.

genae’s Regulatory and Quality group, MedicSense, is ISO13485:2016 certified.

We focus on our customers and aim at exceeding customers’ expectations. The customer satisfaction is measured on a regular basis. The results of the 2019 customer satisfaction survey were in line with previous years and showed that all customers remain (very) satisfied with the services and products genae provides.

Auditing

As part of the QMS maintenance, genae can support your first party (internal) or second party (external at sub-contractors) audits. This can include the preparation of such an audit and the participation in the actual audit. Possible follow up, as the outcome of such an audit, can be processed by the genae team in collaboration with your quality team.

genae continuously passes various vendor, national/regional Competent Authority and FDA audits:

  • 2019 - FDA BIMO, KSA & Taiwan Competent Authority
  • 2018 - ISO27001 Audit, US IRB (2), German, Belgian, Austrian, Netherlands & Taiwan Competent Authority (2)
  • 2017 - German Competent Authority
  • 2016 - FDA BIMO, Czech Competent Authority
  • 2015 - FDA BIMO, Belgian Competent Authority (4)
  • 2014 - FDA BIMO (3), German Competent Authority (2)
  • 2011 - FDA BIMO (2), Austrian Competent Authority
  • 2007 - German Competent Authority
  • 2005 - German Competent Authority

Process validation

genae can support you with the preparation of the validation package for the product release. This can include the:

  • Creation of test scenarios and scripts to ensure quality of new and existing features
  • Assessment of industry-specific regulatory compliance guidelines and regulations

Quality Assurance Manager

  • Act as your QA Manager

genae is on the Approved Supplier/Vendor List of the largest medical device companies worldwide.

How can we help you?

Want to hear more about our services or how we can support your project? Feel free to contact us with any questions you may have.

Contact us