Mobil 2020

Quality management of medical device companies

Quality management system

A quality management system shall guide and support the organization in all aspects related to quality. The management system should be process orientated and user-friendly. The regulatory requirements relevant for the company should be weaved into the processes to ensure compliance. By doing this an ISO 13485 or ISO 9001 certificate becomes more than a certificate, it creates a value for the company.

Fjord Consulting can help you revitalize your current quality management system, or implement a new system. We can also act as interim Quality manager if you have a vacancy.

Process mapping and implementation

Processes that are customer-focused, well defined, implemented, effective and supported by management lead to quality and value for the company.

Fjord Consulting can help you define, implement and improve your processes.

Internal & external auditing

To ensure that processes, projects and suppliers are both in compliance with regulatory and customer requirements as well as effective, they should be audited regularly. It is also a regulatory requirement to plan, perform and follow up on audits.

Fjord Consulting can perform audits of your processes, projects and supplier.

Risk management

To ensure that medical devices are safe, risks related to the use of the device need to be identified and, as far as reasonably possible, be eliminated. Risk analysis should begin early in the development project and be performed throughout the life time of the product. For medical devices risk management shall be performed according to ISO 14971:2012.

Fjord Consulting can lead or support your risk management work.