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Our services
Supporting global Regulatory Affairs projects, from strategic planning to executional ‘hands-on’ regulatory work in pre- and post-market stages
Clinical strategies and planning; plus clinical evaluation writing with a comprehensive assessment of your device’s safety & performance profile
Quality is at the heart of JReg. We offer services in all areas of quality, from developing QMS’s to internal and supplier audits
Our professional coaching will help your internal compliance resources to develop in their role, learn new skills, and gain insight into best practices
Offering person responsible for regulatory compliance in accordance with EU MDR for Manufacturers and Authorised Representatives
Everyone at JEB can honestly say that we are stronger and more compliant since we have been working with JReg. We appreciate the professional and accurate support provided through every interaction. I would have no hesitation in recommending JReg to anyone needing similar services.
JReg has assisted us with our transition to MDR for almost three years. Over the course of this time, Julie has consistently given us excellent technical advice and regulatory guidance; at times impartially validating our own ideas and thoughts and at other times offering us a tactic we hadn’t considered. Julie has been a trustworthy and highly valued advisor to our company because of her professionalism, friendliness, responsiveness, and depth of knowledge. In addition to her strong ability to work both independently and collaboratively, Julie has a talent for bringing people together. She has been a huge asset to our company and I have no doubt that she will continue to be for any other client who seeks out her expertise and services. I would not hesitate in recommending JReg to any prospective clients.
I have known and trusted Julie for years as a colleague, working together in demanding projects (both in terms of know-how as well as deliverables and timelines). In all those years Julie has consistently been a reliable, knowledgeable and committed partner whom I have always trusted for meaningful contribution. Our sparring and joint work has led to consistently successful projects in the Medical Device Regulatory and Clinical field for clients all over the world. More than that, Julie is an absolute joy to work and collaborate with on a daily basis.
All interactions with JReg have been professional and delivered results. We have built a solid partnership with open communication and trust.
A great service from highly knowledgeable consultants. I’d like to specifically call out the help and support we got from James Allard. James has helped us to identify compliance gaps we have, but more importantly what we need to do to resolve them.
JReg is an indispensable service to my business. I only expect high quality and that is what I receive.
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