CT HEALTHCARE TRADING AS NIAGARA PTY LTD

“CT Healthcare has been a medical device manufacturer in Australia for 50 years and have used KD&A on different projects over the last 16 years and they were instrumental in helping our business gain its original TGA conformity accreditation.  Twelve years ago we engaged the services of KD&A, on a regular consultancy basis, to assist us with our Quality Management System and Regulatory requirements.  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

DERMFIX LIMITED

“Dermfix Limited chose KD&A as our Sponsor for entry into the Australian marketplace in 2016 and they continue to professionally support our device registrations for new and existing medical devices with TGA.

Emails are normally answered within a few hours and any issues are dealt with in a timely manner.  Dermfix Limited would be happy to recommend KD&A to other European companies looking to make a similar move.”

Jonathan Lumley-Kelly, Director, Dermfix Limited

PAINCHEK^®

“PainChek^® provides clinical software most commonly used in the aged care sector and have used KD&A regulatory services since 2016.

During this time KD&A has supported PainChek^® with Technical File and Quality Management System (QMS) development, implementation, and internal auditing supporting us with meeting our medical device compliance obligations.

KD&A also completed PainChek^®’s medical device registrations in Australia, EU, Canada, and Singapore. KD&A continues to support us in our FDA PreSub communications and De Novo preparations.

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^®

CARE ESSENTIALS PTY LTD

“KD&A is very professional, knowledgeable and easy to work with. They submitted 510k application for our device; it was completed quickly, and we received approval within a very short time. We have also used their services during external audits; ISO 13485 and MDSAP. They are very tactful with the auditor while holding firm on our company’s way of doing things.”

Upeka Samarakoon, General Manager – Operations, Care Essentials Pty Lt

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

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

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.”

Elastegen became part of Allergan plc in 2018.

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