MEDICAL DEVICES

We get your medical device concept, design, prototype or product approved and on the market FAST.

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.

About Platypus Technical Consultants

Why Platypus?

To bring your medical device to market as quickly as possible you need someone who truly understands the regulations and standards and how to apply them to your technology.

Who better than someone who helped write the regulations and standards?

In his  years as a Senior Assessor/Investigator with the Therapeutic Goods Administration (TGA), our Founder and Managing Director , Dr Lee Walsh, not only learned how the TGA framework operates, he also gained firsthand experience in interpreting the Australian requirements for medical devices.

As the TGA’s lead for digital health, cybersecurity and emerging technology, Dr Walsh specialised in interpreting and applying the regulations and standards to innovative and first-of-kind products.

Dr Walsh was involved in writing both regulations and standards for medical devices and related technology (e.g. the Internet of Things).  So, has 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 and frustrating approval process.

With Dr Walsh’s background in research and development, and Platypus Technical being an established  technology company, we have the perfect blend to understand the medical science and engineering behind your product, and the critical expertise in product validation.

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.

Validation

(clinical and engineering)

Risk Management

Quality Management

Regulatory Affairs

We perform all these functions in one place

In a lot of instances, companies would hire multiple people to fill these roles.  An expensive and frustrating prospect as the ability for three specialists in these fields to effectively and efficiently communicate and co-ordinate sometimes proves challenging, time consuming and expensive.

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.

Validation

(clinical and engineering)

Risk Management

Quality Management

Regulatory Affairs

We perform all these functions in one place. 

In a lot of instances, companies would hire multiple people to fill these roles.  An expensive and frustrating prospect as the ability for three specialists in these fields to effectively and efficiently communicate and co-ordinate sometimes proves challenging, time consuming and expensive.

With Platypus Technical you get:

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An expert in regulation and evidence requirements for medical devices (specialised in Australian regulation; digital health; emerging technology).

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A former TGA senior assessor and investigator, and expert in emerging technology reforms who led reforms for cybersecurity and software.

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An expert in engineering and clinical validation, including the relevant Australian and international standards.

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

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A specialist in digital health products and other medical devices, and associated technology, that include software.

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A specialist in cybersecurity of medical devices who led collaboration with the CSIRO to write the TGA guidance.

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An experienced researcher who is internationally recognised for medical research, validation and development of human instrumentation.

How can we help?

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

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

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

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

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