ISO 13485 specifies requirements for the development, implementation and maintenance of a Quality Management System (QMS) for medical device manufacturers and suppliers. Beyond helping to meet regulatory and compliance requirements, the implementation of a QMS with well-structured processes supports an organisation in improving productivity and efficiency.
The development and implementation of a well-designed QMS requires experience and expertise and the cooperation of a diverse range of subject matter experts from all departments of an organisation. It is therefore a highly individual process and only tailored solutions will lead to a QMS that effectively supports an organisation’s daily activities and is applied and „owned“ by all employees.
Our services for your QMS
Medical Mind can support medical device manufacturers and suppliers by providing the following services:
- Support in the development, implementation and maintenance of quality management systems according to ISO 13485 and ISO 9001
Transition to ISO 13485:2016
- Document control: assistance to identify and document all processes that need to be documented. Our experts always consider your individual needs and view overly complex systems as counterproductive
- Internal audits and pre-certification assessments to ensure ISO 13485 compliance of existing processes and procedures within the organisation
- Communication with notified bodies and competent authorities
- Corrective action & preventive Action (CAPA)
- Complaint management
- Incident and near-incident analysis and if necessary reporting
- Field safety corrective notices (FSCN) and field safety corrective actions (FSCA)
- Notified body audit preparation and support
- Assistance with investigating and closing non-conformities