Expert Regulatory Consulting Services
Save time & money with the KD&A team
Launch products and access new markets
03
Internal Auditing and Support
KD&A will help you ensure your Quality Management System (QMS) is effectively implemented, maintained and aligned with ISO 13485 and applicable medical device regulatory requirements.
KD&A provides internal auditing and audit support services for medical device and IVD manufacturers operating in Australia and global markets, helping you demonstrate that your Quality Management System (QMS) is effectively implemented and aligned with ISO 13485, MDSAP, and applicable regulatory requirements.
Our auditors deliver practical, risk-based audits that assess both conformity and effectiveness, with clear, prioritised actions to strengthen your system and reduce compliance risk.
FAQ 1: What is an internal audit and why is it required?
An internal audit is a structured, independent assessment of whether your QMS is being followed and whether it is working as intended. ISO 13485 requires manufacturers to conduct regular internal audits to verify compliance and drive continual improvement. It is a sampling exercise where documented procedures and records are reviewed to verify compliance with the standard and the manufacturers defined processes.
FAQ 2: Can this service link to regulatory submissions and market access?
Yes. We align audit focus areas with your regulatory strategy so that QMS evidence supports ARTG inclusions, CE marking, FDA submissions and other global approvals.
FAQ 3: Why use KD&A internal audit services?
Using KD&A to execute your planned internal audit program provides you with the peace of mind that you can effectively demonstrate the selection of your internal auditors means that you can ensure objectivity and impartiality throughout the audit program.
Why strong internal auditing matters
A well-designed internal audit program:
- Enables access to regulated markets
- Supports regulatory submissions, approvals and ongoing recertification.
- Reduces compliance risk before regulator involvement
- Improves operational efficiency
- 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.”
Latest news updates
Our team of experts
Kea Dent
Managing Director
Bibiana Franco
Senior Associate
Louise Pirauo
Senior Associate
Mya Imgraben
Associate
Request a Custom Quote
Complete your information below and our team will be in touch.
