Medical Technology
Description
Key areas
- Quality Management System certified to ISO 13485:2016
- IEC 62304 – Medical device software – software life cycle processes
- IEC 60601 – Safety and effectiveness of medical electrical equipment
- FDA and TGA approval experience
Procept has a long and successful track record in the design and development of novel medical devices. Through our work with some of Australia’s most innovative and ambitious startups, we have taken part in work that has made a substantive difference in the medical field.
For those just beginning on their journey to realising their product, there is a great deal to consider at every turn. Exacting standards that are rightfully maintained to the letter can present all sorts of hurdles to those organisations just finding their way.
Develop and execute in a demanding field with the help of Procept
The team at Procept have the experience and expertise to assist in the creation of medical technology and instrumentation that meets even the most rigorous medical standards.
We’ve helped new and existing businesses create devices for regulated markets in Australia, the US and Europe. Our Design for Manufacture process uses our Quality Management System, certified to ISO 13485:2016 standards so you can be sure of a traceable and reliable engineering service.
Our team of highly qualified and experienced engineers understand the rigorous involved in the development of a medical device, including designs which adhere to the following international standards:
- IEC 62304 – Medical device software – software life cycle processes
- IEC 60601 – Safety and effectiveness of medical electrical equipment
From concept and prototyping, through to product evaluation and market research, the team here at Procept can facilitate targeted efforts through each and every stage. Our goal is to get your product to market by providing the right guidance so you can navigate the design decisions and documentary requirements for your product, whether that’s here in Australia or Worldwide.
Our capabilities as an advisory, development and engineering organisation are informed by years of experience in generating results that will see your efforts set for success. For more information on our medical device projects, take a look at the case studies below.
