Expert Regulatory Consulting Services
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Medical Device and IVD Device Classification Assessment
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.
KD&A provides medical device and IVD classification assessment services for manufacturers and sponsors operating in Australia and global markets, helping organisations determine the correct regulatory pathways early in product development.
We develop robust, regulator-defensible classification rationales based on intended purpose, technology, risk profile and jurisdictional rules – allowing you to plan development programs, evidence generation and submission strategies cost-effectively and with minimal regulatory disruption.
KD&A tailors classification assessments to your product portfolio and target markets.
FAQ 1: What is a device classification assessment and why is it important?
A classification assessment determines whether your product is regulated as a medical device or IVD and, if so, what risk class applies in a given jurisdiction. This drives regulatory obligations such as conformity-assessment routes, clinical evidence requirements, QMS scope and timelines to market.
FAQ 2: What factors are considered when classifying a device?
Classification is based on multiple factors including:
- Intended purpose and claims
- Mode of action
- Duration of contact
- Degree of invasiveness
- Patient population
- Software functionality (for SaMD)
- Applicable classification rules and regulatory guidance
FAQ 3: Do you consider regulator and notified-body guidance?
Yes. KD&A reviews applicable legislation, guidance documents, classification rules and precedents issued by regulators, notified bodies and competent authorities to support defensible, evidence-based classification outcomes.
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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Senior Associate
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Associate
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