TRUSTED & CERTIFIED

Medical TECHNOLOGY PROJECTS

Procept have a successful track record in the design and development of novel medical devices. 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 rigours 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

 

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.

For more information on our medical device projects, take a look at the case studies below.

Bsi ISO Product Development

KEY AREAS

  • Design for Manufacture services
  • Manufacturing management
  • Design to IEC 62304 – Medical device software – software life cycle processes
  • Compliance with IEC 60601 – Safety and effectiveness of medical electrical equipment
  • Quality Management System certified to ISO 13485:2016
  • FDA and TGA approval experience

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