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.
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
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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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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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.”
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.’”
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.”
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.”
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.
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
