We provide expert guidance for Global Medical Device & IVD Companies

We help our clients achieve regulatory success and build their businesses

Efficient and practical regulatory solutions in different markets around the world

We can help you launch new products and access new market opportunities

Trusted Regulatory Consultants for Medical Device and IVD Companies

As seasoned regulatory consultants with deep expertise in the medical device industry—including insights from our Managing Director’s experience as a manufacturer—we are dedicated to guiding you through the complexities of regulatory compliance.

KD&A specialise in providing a range of medical device regulatory services to manufacturers, sponsors, and distributors of medical devices, including IVD devices.

We are dedicated to guiding our clients through the complexities of medical device compliance.

Discover how we can support your journey to success.

Medical Device Regulatory Strategy

We work with you to develop a plan that helps to get your medical device or IVD to market quickly and efficiently

ISO 13485 Quality Management Systems

Get the best from your organisation by implementing a KD&A Quality Management System

Global Medical Device Registrations

EU CE Marking, Australia TGA Conformity Assessment and Australian Register of Therapeutic Goods (ARTG) inclusions, US FDA, Health Canada, UK UKCA, Singapore HSA, etc.

Technical File Documentation

Let KD&A help you with the development of Technical File Documentation that complies with the medical device regulations

TGA Sponsor Services

KD&A can assist overseas manufacturers by providing Australian TGA sponsor services and regulatory support.

Post-Market Surveillance

Take the difficulty out of on going compliance using a KD&A Post Market Surveillance System

Our specialised knowledge empowers you to launch your products confidently and access new markets seamlessly.

As expert medical device consultants, KD&A provides you with sound regulatory advice that will save you money and time as you prepare medical devices and IVDs for market launch. KD&A will help you understand early on which regulatory requirements apply, so you can plan ahead to meet requirements cost-effectively and with minimal disruption.

Our Clients

01

Australian Sponsors & Distributors

KD&A can guide your organisation in demonstrating TGA regulatory compliance in the most effective way, to reduce the burden on your organisation and the time to market.

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02

Australian medical device companies, including IVD companies.

At KD&A we specialise in designing ISO 13485 Quality Management Systems and Technical Files for medical devices and providing support with the TGA Conformity Assessment process.

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03

International medical device companies, including IVD companies

KD&A as an expert regulatory consultant, has significant experience with the global regulatory process for medical and IVD devices and can provide a complete medical device solution.

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Australian Dental Manufacturing Pty Ltd

“We could not help but come away with respect for, and impressed with, the service KD&A provided to our company. I would not hesitate in recommending KDA to anyone who needs to deal with TGA regulatory requirements.”

Dr. Matthew Athanassiadis,

Director, Australian Dental Manufacturing Pty Ltd

Brauer Pharma Pty Ltd

“KD&A is one company that stands out for prompt advice and prompt response rates. Not only do they respond immediately – they handle all issues efficiently and even handle ‘attention consuming’ questions and repeat questions with a great deal of grace. Can highly recommend.’”

Peter Oschenham,

Managing Director, Brauer Pharma Pty Ltd, Ellen AB and NYDA products

Opto Global Pty Ltd

“KD&A have been providing Opto global with high quality and professional assistance for 5 years. Their service is delivered efficiently, thoroughly and within the required timeframe.”

Medhat Eldeeb,

Regional Sales Manager, Opto Global Pty Ltd

Bodyflow International Pty Ltd

“KD&A provided Bodyflow with professional, informative and relevant regulatory advice. In addition, the workshop I attended (held by KD&A along with two other regulatory consultants) allowed for interactive learning – growing my understanding of the requirements for our medical device.”

Dean Libertone,

Compliance Officer, Bodyflow International Pty Ltd

Cyclomedica Australia Pty Ltd

In the 2.5 years we have been working together, no task or challenge is too small or too big. They take both extremes with enthusiasm and ownership not often seen with other consultants. In fact, we don’t see them as consultants, they are an integral part of our team.

James McBrayer,

Managing Director & CEO, Cyclomedica Australia Pty Ltd

Our Team of Experts

Our vast understanding of the medical device regulations across the different markets ensures you receive the most accurate and up to date information for your medical and IVD devices.

Kea Dent

Managing Director

Bibiana Franco

Senior Associate

Louise Pirauo

Associate

Mya Imgraben

Assistant

Discover how we can help you achieve regulatory success.

Get in touch with our team.