Procept have a successful track record in medical device product development. We’ve helped new and existing businesses develop and design products for regulated markets in Australia, the US and Europe. Our Design for Manufacture process for medical devices uses our Quality Management System, certified to ISO 13485:2016 standards so you can be sure of a compliant process and reliable medical device outcome.
Our key understanding of medical device companies, experience in developing new concepts or further advancing and revolutionizing an old device ensures your product is in the right hands no matter what stage of development you are in or how little knowledge you have in the industry.
Our team of highly qualified and experienced team provide services which also include design to the following international standards:
· IEC 62304 – Medical device software – software life cycle processes
· IEC 60601 – Safety and effectiveness of medical electrical equipment
Our goal is to get your medical device to market through rigorous development, and providing the right guidance to help you navigate the regulatory pathway for medical devices, whether that’s here in Australia or Worldwide.
Recent examples of our work include the WiTouch by HollyWog LLC, a Class IIa medical device that has helped over 100,000 people in 22 continues.
For more information of WiTouch and our other medical device projects, take a look at the case studies below: