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ISO 13485/ MDSAP QMS Creation and Maintenance
Get the best from your organisation by implementing a KD&A Quality Management System
KD&A provides ISO 13485 and MDSAP Quality Management System (QMS) creation, implementation and maintenance services for medical device and IVD manufacturers operating in global markets.
We help organisations design compliant, practical QMS frameworks that meet regulatory requirements while supporting commercial growth – from early-stage development through to certification, audits and post-market obligations.
Drawing on decades of industry and regulatory experience, KD&A delivers fit-for-purpose systems aligned to your device risk class, regulatory strategy and market-entry plans. Our services cover full QMS build-out, remediation of existing systems, audit readiness and ongoing maintenance.
FAQ 1: What is ISO 13485 and why is it required?
ISO 13485 is the international quality-management-system standard for medical device manufacturers. It is commonly required to access regulated markets and is used by regulators to assess compliance with safety, performance and post-market obligations.
FAQ 2: What is MDSAP?
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit that satisfies the regulatory requirements of multiple jurisdictions, including Australia, the US, Canada, Brazil and Japan.
FAQ 3: Do you support remediation of existing QMS systems?
Yes. KD&A regularly supports organisations with gap analyses, system remediation, process optimisation and regulatory-driven updates following audits or regulatory changes.
FAQ 4: Can this service link to regulatory submissions?
Yes. KD&A integrates QMS activities with regulatory strategies and submission planning to ensure quality systems support ARTG, CE, FDA and other global approvals.
Why a Strong QMS Matters
- Enables access to regulated markets
- Supports regulatory submissions and approvals
- Reduces compliance risk
- Improves operational efficiency
- Demonstrates organisational maturity
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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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