Outsourced Quality Manager
Kasve’s Outsourced Quality Manager and Person Responsible for Regulatory Compliance service enables your organisation to focus on its core competence.
Expert quality management
Kasve’s Outsourced Quality Manager and Person Responsible for Regulatory Compliance service enables your organisation to focus on its core competence. Use the service to gain access to an external expert or team of experts as part of your organisation to the extent you need at a given time. The outsourced Quality Manager will collaborate with your organisation’s leadership and under its mandate in managing your quality management system and ensuring its regulatory compliance.
Quality manager as a service
The legislation concerning medical devices requires that organisations (manufacturer and authorised representative) have access to a Person Responsible for Regulatory Compliance. However, this person does not necessarily have to be employed by your organisation; instead, you can outsource the service. Kasve has expertise and specialists ready to take on these tasks, for instance, until your organisation has had time to train an employee to take care of these responsibilities.
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!
