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
We launched the product as planned
Together with Kasve, Adamant Health built a quality management system on time to enable them to apply for the CE mark for their medical device.
Kasve brought us enourmous Quality Management know-how
Together with Kasve, Kustannus Oy Duodecim has built a Quality Management System in accordance with the ISO 13485 standard, and is developing software product in accordance with the IEC 62304 standard.
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.
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