Cecilia Johansson
Senior Consultant
PhD Medical Genetics
With extensive experience in medical device and in vitro diagnostic (IVD) device product development, Cecilia Johansson has built a strong foundation in design control, risk management and usability engineering. Her expertise lies in integrating regulatory and quality requirements seamlessly into daily processes. Ensuring that compliance becomes a natural part of product development.
More about Cecilia
Before joining RegSmart, Cecilia led R&D teams focused on product development as well as product care for analytical IVD instruments. She oversaw regulatory compliance across key areas such as design control, CAPA, complaint handling and usability engineering. Cecilia also successfully managed the transition from IVDD to IVDR, developing new technical documentation and conducting complementary studies to meet the updated requirements.
Cecilia has participated in several external audits by notified bodies, providing her with a clear understanding of the level of detail, traceability and documentation needed to maintain compliance.
Earlier in her career, Cecilia held leading roles covering verification and validation, risk management and software testing. Positions that gave her deep hands-on experience with quality and regulatory frameworks from an R&D perspective.
With a PhD in Medical Genetics and a background as project coordinator at Uppsala University, Cecilia also brings valuable academic experience, including managing research collaborations and grant application processes.
Cecilia’s approach is pragmatic and grounded. By integrating regulatory requirements into daily routines she ensures that compliance happens naturally, resulting in safe, well-documented products and smoother audits.