Expert Regulatory Consulting Services
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Medical Device Regulatory Strategy Report
We work with you to develop a plan that helps to get your medical device or IVD to market quickly and efficiently.
KD&A provides medical device and IVD regulatory strategy services to help manufacturers plan and execute successful market entry in Australia and globally.
Our Regulatory Strategy Reports define the regulatory pathway for your device, including classification, approval routes, standards, timelines, and costs, so you can make confident development and commercial decisions early.
By identifying regulatory requirements upfront, KD&A helps reduce delays, avoid re-work, and align product development with approval expectations across your chosen target markets.
Each Regulatory Strategy Report includes:
- Device classification by region
- Applicable conformity-assessment pathways
- Relevant standards, guidelines and Common Specifications
- Estimated regulatory fees and approval timelines
- A recommended step-by-step roadmap to market
FAQ 1: What is a Medical Device Regulatory Strategy?
A regulatory strategy is a structured plan that outlines how a medical device or IVD will achieve regulatory approval in specific markets. It covers classification, approval routes, standards, evidence requirements, timelines and estimated costs.
FAQ 2: When should a regulatory strategy be developed?
Ideally before finalising device design or starting major testing. Early regulatory planning ensures development activities align with regulatory expectations and helps prevent costly redesigns or additional studies later.
FAQ 3: Which markets can KD&A cover in a Regulatory Strategy Report?
KD&A prepares regulatory strategies for Australia (TGA), Europe (EU MDR / IVDR), the United States (FDA), UK, Canada, Singapore and other international jurisdictions, depending on your commercial goals.
FAQ 4: Can KD&A support implementation after the strategy is delivered?
Yes. KD&A regularly supports clients beyond strategy development – assisting with QMS implementation, Technical Files, clinical evidence planning and regulatory submissions.
How Our Regulatory Strategy Service Works
- Scoping & Market Selection
We confirm your intended use, device design and target markets. - Regulatory Assessment
KD&A determines classification, approval routes, standards and clinical expectations. - Roadmap Development
We prepare a clear regulatory plan with timelines, sequencing and cost estimates. - Next-Step Planning
You receive practical recommendations for implementation, submissions and QMS activities.
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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Kea Dent
Managing Director
Bibiana Franco
Senior Associate
Louise Pirauo
Senior Associate
Mya Imgraben
Associate
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