genae
Regulatory Affairs
Stay on top of the ever changing regulatory landscape. genae provides a full range of regulatory support services for your pre- and post-marketing medical device development needs.
Quality Assurance
In order to bring your product to the market, it is mandatory for manufacturers to have a Quality Management System in place. genae can support you with the creation of your QMS based on the ISO13485 or ensure the maintenance.
Clinical Trial Management
If you are looking for an expert partner to manage your clinical trial, we’re at your service. As a full-service CRO we support you on all levels and in every step of your clinical research project.
Digital Health
Make sure the quality, consistency and completeness of your data is immaculate and exact. genae provides high-quality Digital Health services including data management, statistical analysis of clinical trial data and electronic data tools.
FDA wants public input on AI-enabled device regulation
The FDA today floated some ideas on how it might regulate medical devices armed with artificial intelligence - also known as software-as-a-medical-device (SaMD) - whose algorithms can change based on machine learning (ML) and possibly affect people in ways for which they were not approved or cleared.
What I appreciate the most about genae is the consistent level of quality they produce. Our medical device study team is knowledgeable, capable and experienced; flexible with our changing needs, and very responsive to our concerns.
— Sara Vidmar, Vice President Clinical & Regulatory Affairs, Mitralign Inc., USA
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.
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