Medical Device Product Development and Designing

Disposables to devices, practitioners to patients. From concept development through the most complex technical implementation, PDT’s medical product experience encompasses a broad range of end-user communities and applications, governed by procedures and project management systems that meet FDA requirements.

Having spent thousands of hours researching how medical devices are used in critical care and home use settings around the globe, our product development specialists truly appreciate the need to integrate front-end creative insight into the procedural rigors of medical device development. Our teams dive deep to understand the myriad users, influencers, and contextual drivers behind a device’s design, then engineer solutions which build on that knowledge to deliver best-in-class ergonomics, ease of use and safety.

With quality, control and documentation procedures fully integrated into all of our disciplines, PDT was among the first ISO 13485 certified product development firms in the world. Our teams follow 60601 guidelines for efficient regulatory agency and Ministries of Health approval, and through extensive input and output design documentation can help support all FDA submission opportunities. Integrated risk assessment / FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis) and verification / validation testing are essential tools we can assist with to see your program through to production, including complete support in the selection and design transfer of your device to FDA approved Contract Manufacturers.

The promise of remotely monitored healthcare – empowering patients and caregivers to conveniently access real-time information critical to wellness and recovery – is fast becoming a reality, and PDT’s combined expertise in wireless, mobile technology and medical device development puts us at the forefront of this sea change in medical care. Whether you envision an entirely new category of product or the addition of wireless capabilities to an existing line, PDT can help your team surmount the challenges of this rapidly evolving market.

Complex medical programs often require process design in addition to product development. more


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