Regulatory Affairs
Kasve can help you at the different stages of regulatory management.
Meet market reguirements
It takes huge effort and diverse competence to launch a medicinal or In Vitro Diagnostic device to the market. We have built a network around the competence of our specialists, bringing together extensive knowledge in solving various regulatory challenges, whether you are seeking to obtain a CE marking or FDA approval.
Kasve can help you at the different stages of regulatory management. We also actively utilise our comprehensive networks to always provide you with the best possible expert to meet your specific challenge.
Broad expertise at your service
We can help you with tasks such as:
- Product classifications, defining purpose and mechanism
- CE marking and FDA approval
- Biocompatibility surveys
- Use instructions and markings
- Risk management
- Required tests and trials
- Usability planning and tests
- Clinical assessment plan
- Clinical validations for in-vitro diagnostics
- Selecting and communicating with a Notified Body
- Competitive tendering and validation of different vendors
Our references
Environment for medical software development to Migrevention
Migrevention is a digital headache clinic solution for patients, specialists, and clinics to manage migraine and other primary headaches. Kasve implemented a project with Migrevention in which an environment was created for the development of medical software.
With the help of Kasve, we developed a marketable medical device in a year
Together with Kasve, Nursie Health built a quality management system for their mobile application, which is a medical device.
Growth requires a quality management system
Nordic Laboratories did a preliminary study with Kasve for the clinical laboratory's quality management system, and is now building the quality management system itself.
Contact us
Do you need a qualified partner to support you?
We help healthtech companies succeed in the international market. Leverage our expertise and our comprehensive network!
