Why KD&A ?

Australian Dental Manufacturing Pty Ltd

“Dealing with today’s regulatory requirements is a challenge. Without KD&A, ADM would have found it hard going to successfully negotiate all the regulations. KD&A’s professional assistance, friendly manner and experience made what seemed to us to be a “Mt Everest” of regulatory requirements into something far less daunting. We could not help but come away with respect for, and impressed with, the service KDA 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

Amcla Pty Ltd

“Working through Australian regulatory processes often appears to be straightforward but in my experience is seldom the case. Black and white are generally not favoured colours by Australian regulatory departments. Successful product registrations can only be achieved through years of experience and detailed knowledge of the relevant  regulations, coupled with professional dedication to achieving results within a commercial timeframe. KD&A have all these attributes and have been of invaluable assistance to our company on a number of quite difficult assignments.’”

Ian Garrow, CEO, Amcla Pty Ltd

Applied Physiology Pty Ltd

“As a startup medical device company we may face many challenges. We have been very fortunate in our selection of consultants, a few are now more like partners to our success as we enter product commercialization phases internationally. Quality Management Systems and Regulatory submissions are necessary gateways to entering the medical device market, KD&A have been and continue to be instrumental in the creation and execution of both these processes. From product development, clinical trials, regulatory submissions and market seeding stages, KD&A has provided sound regulatory advice and robust frameworks for our Quality Management Systems.  We would highly recommend KD&A as a well rounded and very much hands on QMS and Regulatory advisors.”

Alex Campos, Director of Design and Development, Applied Physiology 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

Brauer Pharma Pty Ltd

“Dealing with many supplier companies around the world I am attuned to many delays in response especially when it comes to regulatory affairs. In our first foray into medical devices I have come across one company that stands out for prompt advice and prompt response rates and that is KD&A. 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

CT Healthcare trading as Niagara Pty Ltd

“CT Healthcare has been a medical device manufacturer in Australia for 42 years and have used KD&A on different projects over the last 6 years and they were instrumental in helping our business gain its original TGA conformity accreditation.  Twelve months ago we engaged the services of KD&A, on a regular consultancy basis, to assist us with our Quality Management System and Regulatory requirements.  In the last twelve months 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.  I would highly recommend their services and expertise to any firm operating in the medical or therapeutic goods market.”

Sean Crealey, Director of Operations, CT Healthcare 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

Riverlogic Pty Ltd

“As a new company moving into the Medical Device industry we found the Regulatory Approval process confusing and ambiguous. KD&A were able to offer consulting advice and take care of approval tasks so we could become compliant, with confidence.”

Glen River, Managing Director, Riverlogic 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