Code Blue Consulting Services
Technology and Architecture and Specifications
We have extensive experience with medical signal acquisition and processing in devices from implant to ambulatory. We deeply understand users and environments including home health, EMS, OR and hospital wards. We can help you develop your product and specifications and incorporate the best available technology.We are expert at evaluation of trade-offs and selection of the best technologies from sensors to wireless and can help you incorporate the best solutions for your products.
Product Development
The development of medical devices requires not only good ideas and technology, but also a solid framework of processes and knowledge of existing standards and requirements. We have over 25 years of experience in the development of products in the tightly regulated medical device industry and can help you with all aspects of product development.We work with partners and experienced development groups in all facets necessary to help us bring your vision to reality.
Program Management
Medical device development management is a complex process involving strict control of quality and regulatory requirements with validation and verification as additional layers to the traditional project management leadership role. We have extensive product management experience at all levels and can use it to assist and teach your managers or manage your project as an outside resource.
Regulatory Strategy and Support
We are experts in medical wireless regulatory issues and have extensive experience with wireless technologies and the 510(k) and PMA process. We were involved in several of the first successful 510(k) Bluetooth applications have helped many companies with wireless and other regulatory issues and filings and can help your company too.We have worked with applications involving not only Bluetooth, but also WiFi (802.11 b/g), RFID and WMTS.
Business Development
The medical device business can be difficult to navigate and new markets can be a challenge to scope and understand. We have developed complete business plans for new products and markets and provided analysis and white papers on topics ranging from markets to technologies.We work in a fast and focused way that many companies find difficult to do with internal resources and myriad distractions, providing you targeted results that help you move forward with key decisions.