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
Credibility for a Start-up with a QMS Certificate
Kasve supported Buddy Healthcare in building up the EN ISO 13485 compliant Quality Management System and developed company's internal auditing further.
Etsimo: ISO 13485:2016 Quality Management System
Team Kasve built up together with Etsimo key personnel an ISO 13485:2016 QMS that, for example, enhances the company’s R&D activities, risk management and training of personnel.
Cerenion: ISO 13485:2016 Quality Management System
Kasve helped to build up ISO 13485:2016 QMS that, for example, enhances company’s R&D activities, risk management and training of personnel. Kasve also participated into software development documentation.
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!
