Platypus MedTech Consulting

medical devices

About

Regulation shouldn't be difficult. And it isn't if you work with us. We specialise in helping small businesses and navigate their novel medical devices through the regulation. We specialise in software (inc. AI/ML), digital health, medical device cybersecurity & novel/emerging technology. Our team are researchers and developers who have previously held senior positions inside the Australian regulator, written policy and legislation and served on standards committee and international working groups for medical devices. We know the regulations, standards and how R&D works. Platypus MedTech Consulting know how regulation and government works, and has significant firsthand experience in interpreting the requirements for medical devices and novel technology, and can now apply that experience and knowledge to help bring your new and innovative medical device to market.

Technologies

Outlook Microsoft Office 365 WordPress.org Mobile Friendly Google Tag Manager Google Font API AI Remote Canva Octane

Keywords

medical devices engineering validation experimental design software as a medical device quality management clinical evaluation regulatory affiars digital health medical equipment manufacturing iso 13485 iso 9001 iec 62304 iot medical device regulation standards implementation regulatory risk assessment quality management system international standards compliance regulatory guidance for startups consulting regulatory process optimization regulatory compliance regulatory policy development software as a medical device (samd) risk management systems regulatory audit support software development lifecycle risk management regulatory submission medical device standards

Location

1 National Cirt, Canberra, Australian Capital Territory, Australia, 2600

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