Establishing a Quality Management System
Detailed description
THE COMPANY
Start-up with innovative inhalation technology
THE TASK
The 3R LifeScience was asked to start establishing a quality management system in line with EN ISO 13485 for the approval of a class IIb medical device. For this start-up, we needed to create QMS fundamentals and initially raise awareness for documentation requirements and design control processes for medical devices.
OUR SOLUTION
Our team developed a process landscape and established design and document control processes. In addition, employees were trained in basic QMS requirements in accordance with EN ISO 13485 and MDR focusing on their development activities.
A documentation process for quality-relevant tests was established and staff competencies were determined for further developing and maintaining the QM system.
CLIENT BENEFIT
The client was given a process landscape to help determine what structures and competences will need to be created for a efficient and effective QMS. For this, the basic processes for a quality management system were established and documented to be further developed by the company`s management team.
“We understand that the new medical device regulations affect many organisations and raise many questions.”
Together with one of our experts, you clarify your requirements and questions. If cooperation appears helpful, we will arrange a workshop with you.
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