During the early implementation period of the EU Medical Device Regulation, Ronald was instrumental in partnering with my team and I to navigate the regulation and prepare for the Date of Application. Key areas of focus included:
- Training: Ronald trained the core of our MDR transition team in two days and that gave us a firm basis for our MDR project. He is an excellent teacher and coach, with real-life examples and a style of presenting that keeps us engaged for a full two day session.
- Classification: Ronald identified a potential classification issue in our intended purpose, which he helped in mitigating. During the rest of the project he kept us sharp in identifying creep in our intended purpose, which has now become a second nature of our regulatory team.
- Procedures and Technical Documentation: Ronald helped us creating all our procedures and technical documentation packages with the notified body reviewer in mind. We are now creating documentation that presents a real narrative and operating processes that are easier to navigate.
Once we were well under way we continued to engage Ronald on an ad hoc basis so when we had a question or interpretation we could basically pitch to him. I personally enjoyed these topics as Ronald provided a great sounding board and forum for debate (and banter) on options. In the end, he would come back with a solid, logical and rational answer. This helped our team keep momentum and minimize churn.
Cathi Crist, Sr. Medical Device Cross Functional Leader at Intuitive Surgicalm Inc.
This endorsement is her own and does not represent endorsement by Intuitive Surgical, Inc.