Expert Regulatory Consulting Services
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Software as a Medical Device
KD&A can assist you to most effectively demonstrate compliance with Australian (TGA) and/or European requirements
The last decade has seen rapid growth in advances to computer technology/systems and software development. Accessibility to smartphones and other handheld devices has changed the medical device space drastically, manufacturers can now provide the end user be that the patient, healthcare professional or technical expert, with a device which has the capability to support clinical decisions, control other medical devices, generate and process data as well as so many other options. The development of apps can turn any smartphone or handheld device into a tool to be used as a medical device.
With these rapid advancements, the regulatory landscape has become increasingly complex. KD&A is here to guide you through the regulatory maze, ensuring that your SaMD meets all necessary requirements and is market-ready.
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.
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.
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.
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.
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.”
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.”
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.”
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.”
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.”
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