Quality management
Fjord Consulting offers consultation, advice, coaching as well as hands-on support and training in topics related to quality management and development of medical devices.
Contact us if you have questions regarding MDD/MDR, ISO 13485, ISO 14971, EN 62366, QSR (FDA 21 CFR Part 820), and other regulations with the medical device field.
A quality management system should guide and support the organization. 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 assist in building a quality management system that creates value and at the same time being compliant to ISO 13485.
Contact us for more information.
In a process-oriented organization it is easier for employees to know what to do, how to do it, and who should do it. By measuring the outcome of the processes, the potential for improvement can be identified.
Fjord Consulting can assist in mapping your processes, defining target, and methods for following the output of your processes.
Contact us for more information.
Fjord Consulting perform audits of management systems in accordance with ISO 13485, MDSAP, QSR (21CFRPart20) and other regulations related to medical devices. We can perform internal audits of your company as well as third part audits of your suppliers. Audits review that processes are defined in accordance to defined requirements, and that the processes are adhered to, as well as defines areas of improvement.
Contact us for more information.
Helena Hjälmefjord
Tel +46 722 51 08 69
hhj@fjordconsulting.se
