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Post-Market Surveillance
Take the difficulty out of on going compliance using a KD&A Post Market Surveillance System
KD&A provides Post-Market Surveillance (PMS) system design and implementation services for medical device and IVD manufacturers and sponsors, supporting ongoing regulatory compliance and lifecycle management in Australia and global markets.
We help organisations establish compliant, practical PMS frameworks that combine proactive and reactive monitoring activities – ensuring issues are identified early, regulatory reporting obligations are met, and products remain safe and effective throughout commercial use.
KD&A creates PMS systems specialised to your device type, risk class and market footprint.
FAQ 1: What is Post-Market Surveillance and why is it required?
Post-Market Surveillance is the structured process of monitoring medical devices and IVDs once they are on the market. Regulators, including the TGA and European authorities, require manufacturers and sponsors to collect, review and act on real-world performance data to maintain ongoing compliance.
FAQ 2: What does a PMS system typically include?
A PMS system usually includes complaint handling, adverse-event reporting, trend analysis, corrective and preventive actions (CAPA), field safety corrective actions, recall procedures, post-market clinical follow-up where required, and periodic regulatory reporting.
FAQ 3: Can you design PMS systems for Australian and overseas requirements?
Yes. KD&A designs PMS systems aligned to Australian TGA requirements as well as EU MDR / IVDR and other international regulatory frameworks.
Why strong PMS systems matters
A well-designed Post-Market Surveillance system:
- Protects patient safety
- Maintains ARTG and global market access
- Reduces regulatory risk
- Enables early detection of product issues
- Supports recalls and field actions if required
- Demonstrates organisational maturity and governance
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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