Expert Regulatory Consulting Services
Save time & money with the KD&A team
Launch products and access new markets



Expert Regulatory Consulting Services to help you launch products and access new markets.
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.
KD&A specialise in providing a range of medical device regulatory services to manufacturers, sponsors, and distributors of medical devices and IVD devices.
With over three decades of experience in the medical device sector, Kea possesses a wealth of expertise, having worked as both a medical device manufacturer and regulatory consultant
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.
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.
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/MDSAP QMS Development and Support
Get the best from your organisation by implementing a KD&A Quality Management System.
ISO 13485/MDSAP QMS Development and Support
Get the best from your organisation by implementing a KD&A Quality Management System.
Technical File Documentation
Let KD&A help you with the development of device specific Technical File Documentation that complies with the medical device regulations.
Technical File Documentation
Let KD&A help you with the development of device specific Technical File Documentation that complies with the medical device regulations.
Global Medical Device Registrations including ARTG Inclusions/TGA Registrations
Get your IVD or medical device onto the Australian market quickly with a TGA product registration by KD&A.
Global Medical Device Registrations including ARTG Inclusions/TGA Registrations
Get your IVD or medical device onto the Australian market quickly with a TGA product registration by KD&A.
Medical Device Classification Assessment
Classification assessment and rationale is an essential starting point for medical device and IVD manufacturers and/or sponsors.
Medical Device Classification Assessment
Classification assessment and rationale is an essential starting point for medical device and IVD manufacturers and/or sponsors.
TGA Conformity Assessment/CE Marking
KD&A can assist you to most effectively demonstrate compliance with Australian (TGA) and/or European requirements.
TGA Conformity Assessment/CE Marking
KD&A can assist you to most effectively demonstrate compliance with Australian (TGA) and/or European requirements.
Australian TGA Sponsor
KD&A can assist overseas manufacturers by providing Australian TGA sponsor services and regulatory support.
Australian TGA Sponsor
KD&A can assist overseas manufacturers by providing Australian TGA sponsor services and regulatory support.
Promotional Materials Review
Ensure all your advertising material complies with the applicable regulatory requirements.
Promotional Materials Review
Ensure all your advertising material complies with the applicable regulatory requirements.
Post-Market Surveillance
Take the difficulty out of on going compliance using a KD&A Post Market Surveillance System.
Post-Market Surveillance
Take the difficulty out of on going compliance using a KD&A Post Market Surveillance System.
Software as a Medical Device (SaMD)
KD&A can assist you to most effectively demonstrate compliance with Australian (TGA) and/or European requirements.
Software as a Medical Device (SaMD)
KD&A can assist you to most effectively demonstrate compliance with Australian (TGA) and/or European requirements.
We pride ourselves on providing excellent
customer service to our clients

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

CT Healthcare
We have found KD&A’s service, support and understanding invaluable in helping to guide our business through different situations that have arisen. Their work has been done in an extremely professional, efficient and prompt manner, which has been important in situations where immediate action has been needed.
Sean Crealey,
Director of Operations, CT Healthcare

SPD Development Company Ltd
In the 5 years we have been working together, we have found KD&A to be helpful, knowledgeable and always professional. Their ability to provide clear, accurate and timely responses to regulatory enquiries has been valuable to our business.
Graham Howard,
Regulatory Affairs Manager, SPD Development Company

PainChek
We have found KD&A’s services to be solution driven, the team is professional and efficient. I highly recommend KD&A regulatory services and expertise.
Philip Daffas,
CEO, PainChek

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

Elastagen Pty Ltd
“KD&A have provided invaluable quality management system and regulatory support as Elastagen has successfully transitioned from an R&D organisation to a clinical stage medical device company operating in compliance with ISO 13485 & 21CFR820. KD&A have been by our side from day 1 and are always available to help with any of our regulatory questions.”
Orsola Regaglia,
Operations Manager, Elastagen Pty Ltd

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

Signostics Ltd
“We have used KD&A’s services since our inception. Initially, KD&A managed the creation of our quality system, which they implemented quickly and efficiently. Since the initial engagement we have grown and employed quality and regulatory managers, with KD&A continuing to provide quality management and regulatory affairs advice. They have always been responsive and totally professional in their approach and dealings. We have no hesitation in recommending them.”
Stewart Bartlett,
COO, Signostics Ltd

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