Join us at BIOMEDevice Boston 2023
The Bluefruit Software team is attending BIOMEDevice Boston from September 20-21.
You can talk with us in person at booth 351 ready to answer all your medical device software questions.
- When do I need to start complying with IEC 62304?
- What does an effective V&V process look like?
- How can I improve my medical device’s chances of success?
- How do I reduce my time-to-market through shorter software release cycles?
- What’s involved in bringing automated testing to medical device software?
- How can I make documentation easier using living documentation?
- Can Agile UX practices fit with meeting IEC 62366?
- … and many more!
Want to book a time to speak with us or meet up in Boston? Please grab a slot with our team.
Why speak with Bluefruit at BIOMEDevice Boston?
Our compliance experts, software testers, software engineers, software analysts, and UX specialists have worked on various medical device projects spanning European and North American markets.
Bluefruit’s approach to medical device software development and testing aligns with ISO 13485, and we use Lean-Agile processes informed by AAMI TIR45:2012 to help us do this.
With work that’s led to products gaining regulatory approval and reducing time-to-market, our teams can work directly with your existing in-house talent or help you scale up from nothing.
Come find us at stand 351 or book a meeting.
Leading medical device partner
Diagnostic device case study: client gained FDA approval through effective Verification and Validation
Our client is a large international company working to disrupt the current healthcare testing process with a new point of care diagnostic testing device. Their product is aimed at both the European and US markets. Here’s how Bluefruit Software worked with an existing project team, including several outsourced partners, to support development of a new medical device.
Product development insights to get ahead
❝ Bluefruit provide a professional, innovative and technical team in a very friendly environment. They display a culture of continuous improvement in everything they do for us, this and their positive approach to every challenge makes them a great partner to work with. ❞
❝ With years of working together, we regard Bluefruit as a valued extension of our internal product development team. ❞
❝ A 'can do' approach shines through on each project, with customer satisfaction very much at the top of the list. ❞
❝ Starting out, we knew that embedded software represented one of the most critical pieces of our development roadmap. We needed to quickly find a way to build out a secure and robust solution that would not require us to go back and rework most of the software. Buzr met with over 30 software development companies/contractors in order to find the right partner to help us on our journey. Bluefruit was an easy choice due to their expertise and working style. Using an Agile approach, we were able to structure our work with Bluefruit into individual sprints with well-defined goals. This allowed us to iterate on the embedded firmware with the Bluefruit team while also iterating on other aspects of the company, such as the hardware design & funding stages. As an early stage start-up, this was critical. ❞
❝ Paul and his team have worked with us on a number of projects and bring an extra dimension to software product development in terms of their commitment and technical expertise. ❞