Platypus MedTech Consulting Logo - medical devices

Platypus MedTech Consulting

medical devices
China's Best One-Stop Medical Equipment Provider
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
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Keywords
medical devicesengineeringvalidationexperimental designsoftware as a medical devicequality managementclinical evaluationregulatory affiarsdigital healthmedical equipment manufacturingiso 13485iso 9001iec 62304iot medical device regulationstandards implementationregulatory risk assessmentquality management systeminternational standards complianceregulatory guidance for startupsconsultingregulatory process optimizationregulatory complianceregulatory policy developmentsoftware as a medical device (samd)risk management systemsregulatory audit supportsoftware development lifecyclerisk managementregulatory submissionmedical device standards
Company Information
  • Employees2
  • Founded2017
Location

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

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