As Senior Director, Medical Devices, Johnny is responsible for the management of the Medical Device activities of the whole VCLS group of companies, which includes IWAC Medical Device RA & QA, VCLS Digital Life Sciences (DLS) and VCLS Advanced Health Technologies (AHT).
Johnny has more than 24 years’ of management experience within different industries, which includes 11+ years of QA/RA management positions in the Medical Device industry.
He brings hands-on experience in the successful establishment and integration of Quality Management System requirements compliant with ISO13485, ISO9001, 21CFR820, MDSAP, ISO14001, MDD, and MDR, with focus on implementing QMS processes with high focus on simplicity and aspects of adding value to the organization.
Johnny has years of experience in leading interactions with multiple regulatory bodies e.g. Notified Bodies and National Health Competent Authorities.
The experience includes product development and manufacturing of Class I, II and III devices, active devices, software solutions, and APPs. Johnny has achieved significant experience in the establishment of medical device design control processes, both in terms of compliance with ISO13485 and 21CFR820, but also with the integration of measures for planning and provision of the needed documentation to ensure timely and efficient product registration.
Prior to VCLS, Johnny Hansen has worked in many different roles, all based in QA and RA Departments. The roles were varied and provided a broad range of experience including project management.
Johnny holds a BSc, Engineer, Electronic – Engineering College of Copenhagen (1989), held the position of Lieutenant – Military school, Høvelte (1991) and has a Business Diploma, Personnel Administration – Commercial school in Ballerup (1996)
Johnny is based in Denmark in our IWAC office.