|
     
|
"The Decus team has been instrumental in providing leadership and technical support for our very complex Vapor Generator development project. The project team includes a mechanical design company, software development engineer and an electrical design company who is also the contract manufacturer. When Decus joined the effort the design control documentation was well behind the development of the Vapor Generator. Grace and her team took a matter of fact approach to getting the documentation in a state that was both helpful for the development team and painless in terms of its impact on the project schedule. The Decus team members were flexible in their approach to solving problems, hardworking and routinely met or exceeded their commitments despite having to balance the requirements of other clients. I would definitely give Decus very high marks in terms of their “can do” attitude and strong experience and knowledge base on handling complex development projects like this."
Doug Alleavitch Vice President, Operations and Quality
“Decus has truly been our partner in Quality System implementation and design, offering high quality and timely work for the company. We have also engaged their clinical group who has come through in a very tight time frame with high quality clinical documents, statistical design and analysis, and day to day help in the execution of large human subject study. No question, we would work with Decus again.” Erica Rogers
“The Decus Biomedical team provided regulatory, clinical and quality system consulting services from conception of MiraMedica through successful FDA approval of our product, Mammography CAD. Grace Bartoo, General Manager of Decus, functioned as MiraMedica’s acting V.P. of Regulatory Affairs and helped lead the efforts on regulatory strategy, designing and executing multi-site clinical studies, meetings with FDA, preparing 510(k) and PMA submissions, and organizing for FDA inspections. Decus originally created our Quality System and was helpful in transitioning the system to Kodak Health Group CAD. After acquisition, Grace helped support getting FDA approval, CE mark, and Canadian approval for our product. With Grace’s help we were able to go from concept to a PMA submission in only three years. I would certainly use her team again." Wido Menhardt
“Decus Biomedical has been a partner in the development of our company’s regulatory and quality systems since 2003. Decus Biomedical has been involved not only the development of our RA/QA strategies but also of the best methods for implementation with our team. In addition, Decus Biomedical has taken the lead role in key FDA submissions for our products with very successful results. The ability to address strategy, implementation, and project leadership has made Decus Biomedical an incredibly valuable partner for our company. The fact that Grace Bartoo, general manager of Decus Biomedical, demonstrates great flexibility and versatility in working with us only adds to their appeal.” Ron Yamamoto Chief Scientific Officer
"Decus was responsive to our needs. They guided our five person company, with no prior experience in the regulatory environment, through the 510 K process to successful completion of FDA compliance is less than four months. I highly recommend them." Albert A. Comparini Ph.D., M.B.A.
Client and Project Details
Aegea Medical, Inc. is an early stage medical device company
devleoping technology for the in-office treatment of excessive menstrual bleeding. Our work with Aegea included:
Allux Medical, Inc. was a seed-stage medical device company founded by a medical doctor (Michael Gertner) and a serial entrepreneur (Erica Rogers). Allux Medical is developing technology for the treatment of allergic rhinitis. Our work with Allux:
MiraMedica developed the Mammography CAD product. After completion of clinical trials and submission of PMA, MiraMedica was acquired by Eastman Kodak Company. The product was launched in 2004. Our work with MiraMedica and Kodak HG-CAD:
iScience Surgical is focused on developing high-resolution imaging systems and microsurgical instruments for the treatment of glaucoma. Glaucoma is a sight-threatening circulatory disorder of the eye that affects approximately 4.2 million Americans and 69 million people worldwide. Our work with iScience Surgical:
Our work with Televital:
|
||||||||
|
|
