CYCLOMEDICA AUSTRALIA PTY LTD

“Cyclomedica is best known for our proprietary product Technegas. Invented and manufactured in Australia, Technegas is a nuclear medicine lung ventilation imaging agent that is now used clinically in over 60 countries throughout the world.  They are trusted advisors that assist us in navigating through the drug and device regulations that apply to our product in the many regulatory jurisdictions that we supply. KD&A not only support us in our ongoing commitment to continuous improvement, but they have also been an instrumental partner both in our recent transitions from MDD to MDR and as a key support in maintaining our compliance to MDSAP.

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 and CEO, Cyclomedica Australia Pty Ltd

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

SPD DEVELOPMENT COMPANY LTD

“The Clearblue® brand is recognised the world over as providing accurate home pregnancy, fertility and ovulation tests. 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 – International, SPD Development Company Ltd.

DYNEK PTY LTD

“DYNEK is Australia’s only manufacturer of Class IIb and Class III Non-absorbable and Absorbable sterile surgical sutures. Based in South Australia, DYNEK has been in operation since 1974, supplying to the Australian market as well as to over 60 countries around the world.

DYNEK has used the services of KD&A many times over the past five years and found KD&A to be very professional.

KD&A offer exceptional consulting services and regulatory advice at reasonable fee rates.

Response times to questions is typically one or two business days, and Kea’s approach to the preparation of Class IIb and Class III Technical Files is very well structured, which assists in the reading and assessment of Technical Files by our Notified Body.

DYNEK appreciates KD&A for its services.”

Peter Paraniuk, Quality Control Manager, DYNEK Pty Ltd

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 Ltd

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 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

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.”

Orsola Regaglia, Operations Manager, Elastagen Pty Ltd

Elastagen became part of Allergan plc in 2018

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