Design Control
VLF Consulting supports companies in understanding and implementing Design Control according to 21CFR820 and ISO 13485, with the creation of suitable procedures to guarantee control of the design and development process. VLF Consulting also manages on behalf of its Clients the Quality Engineering activities necessary to guarantee during any project that the activities are carried out according to the aforementioned regulations.
Risk Management according to ISO 14971
VLF Consulting assists medical companies in drafting and maintaining risk analyzes according to ISO 14971.
Design Validation and Usability
VLF Consulting assists companies to ensure that Design Validation activities are carried out ensuring satisfaction of the requirements requested by the Client. It also organizes Usability activities compliant with the IEC 62366-1 standard.