What I do
“I specialise in regulatory strategy and compliance for medical devices, I navigate complex regulations, including UK MDR, EU MDR, and FDA guidelines. My expertise extends to implementing ISO 13485 quality management system audits and ensuring rigorous adherence.
Risk management in accordance with ISO 14971 is a key aspect of my work, as I diligently assess and mitigate potential risks associated with medical devices. I am well-versed in usability engineering practices outlined by IEC 62366-1, ensuring that devices are designed with the end-users in mind.
Post-market surveillance is a priority, with ongoing monitoring of product performance and prompt issue resolution. I liaise with certifying and notified bodies to facilitate smooth certification processes.
I am also well-versed in NHS standards and requirements, such as DTAC, aligning products with healthcare system needs. With a pragmatic and empathetic approach, I advocate for balanced and user-centric medical device regulation and usability engineering practices, ensuring optimal outcomes for both stakeholders and end-users.”
Jan
My Expertise
User experience research
Usability studies
Human Factors
Regulatory compliance
Regulatory strategy support
Instructions for use