Testimonials

Like many medical device manufacturers throughout the EU, we are undertaking the gargantuan task of upgrading our technical documentation to comply with the MDR (EU) 2017/745. A major part of this work has been sub-contracted to clinical data experts at novineon CRO GmbH since they generated our original MDD clinical evaluation. It is fair to say that we have all been a) stupefied and b) enlightened by the order of magnitude increase in: depth, detail, rigour, completeness, cost and effort of MDR compared to MDD. Our well-known, multinational Notified Body declared the omissions in our technical documentation as “possibly insurmountable”. The Clinical Evaluation and complex associated fields required a dive so deep we could not see the bottom, but, the two experts at novineon committed themselves to overcome this frightening challenge.

They worked with our Quality and Regulatory Affairs Managers for nearly one whole year and produced a set of documents, reports, protocols and plans that was so complete, scientifically rigorous and unequivocal that they have satisfied our Notified Body and therefore the MDR. In so doing, we have developed a close and deeply satisfying working relationship with these guys that has transformed our company but also possibly added a new level of understanding and skill at Novineon in truly addressing MDR requirements. Solving this challenge has been vital and rewarding, working with Novineon has, and will continue to be, a priority and a pleasure.

Renfert GmbH has been working with novineon CRO for many years on clinical evaluations for our medical devices. We greatly appreciate their high level of expertise and direct, targeted communication. Good planning and clear specifications have always enabled us to complete our projects without any problems. We look forward to new joint projects that we can carry out together with novineon CRO.

For years, novineon has been a reliable, quality-oriented and highly valued partner for clinical evaluations. Their flawless communication, courteous manner and professional and personal understanding make even complicated projects easy to handle.

We were completely satisfied with our collaboration with novineon CRO GmbH on the CHRONICLE study. In addition to the overall high quality of the work, the trusting cooperation and uncomplicated scheduling with short response times contributed significantly to the successful completion of our study.

Thank you very much for your professional work on the FDA 510(K) submission, your input in responding to the deficiencies and, of course, for answering my constant questions.

I always felt that I was in very good hands with you.

We were extremely satisfied with our collaboration with novineon in the context of regulatory due diligence for our investment in "Ackermann Instrumente". We were particularly impressed by the team's in-depth expertise and proactive input, which went beyond simply answering our questions and will also benefit our new portfolio company in the long term.

The Medi-Globe Group has been working closely and trustingly with novineon CRO for several years. novineon has helped and continues to help us with the content and creation of all clinical documents as part of the certification process, advises us on important issues such as regulatory requirements under the MDR or in communication with notified bodies. novineon has been a major help in reorganising our clinical documentation and implementing our desired structures. We can also always rely on their expert advice when it comes to planning and implementing clinical documents, right through to planning studies for new developments. novineon's service is comprehensive, timely and reliable.