Regulation shouldn't be difficult.

We get your medical device innovation approved as efficiently and simply as possible.

Fully understanding how to interpret and apply the regulatory requirements for safety, performance, and quality are the key to the smooth and fast approval of a medical device.

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How we can help

If you’re a small or medium size medical devices business (or startup), and you have a:

new prototype but are not sure about the regulatory requirements that apply to your product.
Platypus MedTech can help define a regulatory pathway for your products and provide ongoing advice as it’s developed.

completed product, but no Quality Management System (QMS).
Platypus MedTech can design and implement a QMS around your product, and support collection of the missing validation evidence and regulatory certification.

medical device and a QMS and are ready to apply for market access.
Platypus MedTech can help you prepare your submissions, interact with the regulator’s experts, and manage the process.

medical device on the market that is under investigation by a regulator.
Platypus MedTech can help you interact with the regulator, generate the required evidence and revise your documents and QMS to meet regulatory requirements.

Why do clients choose to work with Platypus Technical?

Well, put simply, it’s because we have the unique ability to combine several vital components that speed and smooth the approval process while reducing costs.

Regulatory affairs

Navigating medical device regulations, preparing submissions and dealing with regulators.

Quality management

Required for most medical devices. We help you build a quality management system to meet regulatory requirements, and help you run it.

Risk management

Required for all medical devices. We help you setup systems to manage medical device risk and meet regulatory requirements.

Product evaluation

The process of testing that designs work, and products perform as expected. We help you design your engineering and clinical evaluation programmes.

We perform all these functions in one place.

In a lot of instances, small businesses will hire multiple people to fill these roles. This is an expensive and frustrating prospect as the ability for specialists to effectively and efficiently communicate and co-ordinate proves challenging and time consuming.

With Platypus MedTech Consulting you get:

Experts in regulation and evidence requirements for medical devices who are specialised in digital health, emerging technology, small business and start up.

Former TGA senior assessors and investigators, including people who led reforms in cybersecurity and software regulation.

Experts in engineering, clinical evaluation and application of the relevant Australian and international standards.

Experts in the design and implementation of Risk Management and Quality Management Systems that conform to international regulatory standards (e.g. ISO 13485, ISO 14971, IEC 62304)

Specialists in digital health products and medical devices, and associated technology, including software.

Specialists in the cybersecurity of medical devices, including those who led collaboration with the CSIRO to develop the TGA guidance.

Experienced researchers and developers who are internationally recognised in their fields, which include medical research, computer science, validation and human instrumentation.

Why Platypus MedTech Consulting?

To bring your medical device to market as smoothly as possible you need someone who truly understands the regulatory framework, relevant standards and your technology.

Regulatory experience

During their time working at the Therapeutic Goods Administration (TGA), our team not only learned how the TGA framework operates, they also gained firsthand experience in interpreting the Australian requirements for medical devices.

Medical device & government expertise

Our team has experience writing both regulations and standards for medical devices and related technology (e.g. the Internet of Things). So, we have a deep understanding of how standards are developed, interpreted and applied as well as how regulators operate and do business. This is invaluable knowledge when assisting our clients navigate the complex approval process.

Digital, software & innovation

Members of our team led regulatory reform for the TGA relating to cybersecurity and emerging technology, and specialised in applying the regulation to novel and innovative products.

Technology designers

Our team are experienced researchers, designers and developers, and Platypus MedTech Consulting is an established technology company, so we understand the medical science and engineering behind your product, and have the critical expertise in product validation.