I highly recommend Ronald’s PRRC training series. I joined the April 2023 session and we had a blast discussing real life cases and dilemma’s we encounter navigating the complexity of legislations, technology, budgeting, social interactions and personal integrity.If you ever wondered what the differences are between the QA, RA and PRRC roles, this training is … Read more
I was looking for PRRC training for the SOPHiA Genetics team that would be practical and provide more insight than repeating what I can read. I was searching for someone with real-world experience that could be applicable to our situation and we found it in Ronald. There were other training offers, but Ronald customized this … Read more
Active Implants has been working with Ronald for several years. During that period he has helped us determine strategies to effectively navigate through evolving regulatory compliance environment and through regulatory challenges.Ronald helped us with our communication with competent authorities and notified bodies, and helped us in defining risks acceptability considering the benefit of our devices. … Read more
I’ve known Ronald for many years and know him to be a true expert in the field of QA/RA! He is a frequent contributor to the Elemed MDR/IVDR forum – a platform designed for conversation about the new regulations in Europe. He always shares insightful and interesting answers which truly help the community by tackling bigger problems … Read more
Thank you for a very helpfull piece of advise, when you suggested that I should write a rationale for me being appointed as PRRC in my company. Only a few days later, the auditor asked for it during our Tech File Assessment before (hopefully) achieving our MDR CE certificate.
Ronald has unique ways of approaching a problem. He always looks at it from multiple perspectives and is great at seeing what could be lurking around the corner, or which may have been put in a closet out of sight. Personally I like to discuss complex borderline and classification issues with him and he is … Read more
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: Once we were well under way we continued to engage Ronald on an ad hoc basis so when we … Read more