Expertise

pi1

Product Development planning and documentation

pi22

Safety standards analysis and test management

pi333

Manufacturing search, selection and setup

Product Development
planning and documentation

  • Product management across all lifecycle stages.

  • Design Control Documentation to all key ISO standards.

  • Outsource design vendor management

  • Rigorous design review for quality outcomes.

Safety standards analysis
and test management

  • Product Safety Test Planning

  • Global compliance for key standards – IEC 60601, IEC 61010, IEC 62304

  • Selection and management of external test organisations

Manufacturing search,
selection and setup

  • Global Manufacturing search and selection.

  • Production process design and validation.

  • Transfer from design to manufacture.

Blue Curve – made in Australia,
reaching the world.

Blue Curve is located near Melbourne¬†–¬†Australia’s creative capital. From here we work with medical device innovators around the world.

Company Director Tom Stamp is highly experienced in medical device development, manufacturing and regulatory approval. Our team of area experts covers hardware, mechanical, software and systems design.
Our document writers are experienced with all key IEC, ISO, FDA, TGA and CE medical device standards.

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