Hello Michael,
Thank you very much for your commitment to our project! Finally, a consultant who doesn't just talk but actively gets involved and brings about solutions! I have rarely experienced someone who is equally competent on all levels of medical device development: team leadership and management, technical expertise and deep expertise in regulatory requirements. Your unwavering positive attitude and optimism never failed to impress me. With these qualities, you led the project team through all the ups and downs and brought the project to a positive completion!
Thank you very much for the excellent cooperation,
Martin
Martin S.,
Chief Engineer
Large Corporation in medical technology
Hi Michael,
I just wanted to send you a big "Thank you"! I have reviewed and approved the biocomp. assessement and chemical characterization information supporting the products. I think these assessements and their supporting evidence turned out really, really great!
I'm appreciative that you added in the FDA colorant reference in the biocomp. assessment. I am also hugely grateful for all of your extra effort and time spent on updating the biocomp. assessment to tell a much clearer story. Reading through this document now, it is much easier for me to understand what we did and why. I know your intial update scope was limited to updating the documents, and the scope just exploded into a much larger project. Thank you for taking on the extra work, even though you didn't have to. I think the evidence and the project are all the more better for your efforts.
Thank you,
Brittney
Brittney L.,
Staff Regulatory Affairs Specialist,
US based Top 10 medical device company
Hello Michael,
It was an impressive performance which you achieved on the one hand as project manager, and on the other hand as a professional all-rounder in our project! Successfully managing a multidisciplinary project with so many employees from different companies involved is a mammoth task. Thank you for allowing me to learn so much from your management methods and the techniques you used. And thanks to your help, we were able to successfully cross the finish line!
Thank you very much,
Damir
Damir P.,
Department Manager IONM
Medium-sized Medical Device Company
Hello Michael,
I have already worked with you on several development projects, and each time you were able to convince with your technical and leadership competence. Your in-depth knowledge of medical device development, and especially in the areas of biocompatibility, cleaning and sterilization processes, including the respective regulatory requirements, represent a great added value for every project and every organization. You are able to quickly familiarize yourself with new topics and integrate yourself into new teams. Your open way of communicating quickly makes you a recognized team member who can be relied on at any time.
Thank you for your commitment, I hope that we will have the opportunity to work together in the future!
Jürgen K.
Manager R&D
Major corporation in medical technology