Regulation meets corporate culture: How management systems in medical technology can be effectively designed.
Management systems offer opportunities for design. Julia Englert's presentation shows how MedTech companies can transform regulatory requirements into vibrant structures with meaning and impact, and design shared growth.
Regulatory requirements such as (EU) 2017/745 and ISO 13485 shape the medical technology industry and require comprehensive management systems. However, these are often perceived as a bureaucratic burden. However, practical, organization-appropriate quality management can not only ensure compliance, but also contribute to the lived corporate culture. The presentation will show how companies can design their management systems to balance efficiency, employee satisfaction, and regulatory requirements.