AEGEA MEDICAL Inc.
“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.”
Aegea Medical, Inc. is an early stage medical device company developing technology for the in-office treatment of excessive menstrual bleeding.
Our work with Aegea included:
- Design control activities and documentation
- Writing product and engineering level requirements
- Support engineers in the production of design outputs
- Conducting and documenting risk management activities
ALLUX MEDICAL Inc.
“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.”
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 included:
• Helping establish the Quality System
• Designing and producing clinical study case report forms
• Clinical study database design, data entry and data management
• Clinical study data analysis
KODAK HG-CAD, MIRAMEDICA
“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.”
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 included:
• Developing the regulatory strategy
• Establishing Quality System processes for FDA and ISO 13485
• Quality System training
• Designing and executing multi-site clinical trials, including a receiver-operator characteristics (ROC) study
• Leading FDA meetings, including inspections
• Writing the PMA for the Mammography CAD algorithms
• Writing 510(k)s for the Case Input Station and Report Station products
• Acting as VP, Regulatory Affairs
• Conducting internal audits
• Transitioning the Quality System to Kodak HG
• Leading Notified Body Inspections for ISO 13485 and CMDCAS
ISCIENCE SURGICAL, Corp.
“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.”
iScience Surgical is focused on developing high-resolution imaging systems and microsurgical instruments for the treatment of glaucoma.
Our work with iScience Surgical included:
• Developing the regulatory strategy
• Guiding the development of Quality System processes for FDA and ISO 13485
• Developing the software lifecycle related processes
• Writing the 510(k)
• Writing design documentation
• Conducting internal audits of the Quality System and clinical trials
• Overseeing study monitors
• Managing study data
“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.”
Televital is the only company that offers integrated Electronic Patient Medical Record and real-time telemedicine software modules with unique auto-recognition and configuration architecture that enables plug-n-play for a widevariety of medical devices from different manufacturers. As a patient is evaluated, all test data is made available in real-time to authorized healthcare providers located anywhere in the world, and simultaneously and automatically stored in the patient’s electronic medical record, which also contains the physician’s diagnosis and other medical and demographic information.
Our work with Televital included:
- Developing the regulatory strategy and providing on-going guidance
- Collaborating with their team to produce the 510(k) application
- Guiding the development of design documentation