Agile Product Development Under Design Controls
We built our ISO 13485 certified quality system to work for us and our clients, not the other way around
With our team of highly experienced engineers and project directors who come from engineering backgrounds, we take efficient product development seriously. We’ve combined the best parts of the Agile development process traditionally only used for software development and applied it across all engineering disciplines, and structured it around a traditional waterfall phased approach for medical devices.
The result is a development approach that is both rapid & efficient (especially early on when many design iterations may be needed to hone in on the best approach), but also structured and methodical in terms of design controls and risk management to ensure medical devices we design are safe, effective, and meet our client’s business needs.
Broad Experience Fosters Disruptive Innovation
Leveraging cross-industry knowledge to deliver cutting-edge medical device solutions
At Tensentric, our team has both breadth and depth of experience and has completed over 350 design and development projects since founding, with many of our team members completing hundreds in their careers before Tensentric. This exposure to a growing library of projects and technologies enables our team to bring fresh ideas and innovative solutions to every project we work on.
Our engineers are passionate about staying up-to-date with the latest and greatest technology, allowing us to provide our clients with the most suited and effective solutions for their medical device development needs. By outsourcing medical device product development to Tensentric, you can benefit from our team’s accumulated expertise and knowledge, and can be assured that your project will be in good hands.
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Our Clients Include…
We serve a broad spectrum of clients from early-stage start-ups through large and well-established medical OEMs.