KD&A Can Help You From the Start – Medical Devices Steps to Market


Do you have a medical device and don’t know what to do?

Medical devices include a wide range of products from bandages to heart valves and in most regions, the term medical device also includes in vitro diagnostic (IVD) devices. If you are lost in the regulatory maze, don’t panic, KD&A can help you out.

The Medical device regulatory framework is complex and varies significantly from device to device and region to region. KD&A has more than 21 years of experience working hand in hand with manufacturers, sponsors and distributors through the different regulatory processes. KD&A has the know-how, skills, and services you need to get your medical device to market.

As a medical device manufacturer, compliance with regulatory requirements is a vital step in getting your device to market. KD&A has developed the KD&A’s Steps to Market to help you find out what you need to demonstrate compliance. We can assist you with each step described.

Step 1: Regulatory Strategy – The Regulatory Strategy will help you to understand what you need to do; when you need to do it, and how much it will cost. KD&A can provide you with the Regulatory Strategy specific to your device. This is your ‘road map to market’.

Step 2: Quality Management System Development and Implementation – All manufacturers of medical devices classified above class I require a quality management system. KD&A specialises in building and maintaining quality management systems based on EN ISO 13485 and medical device regulations. We design, and can also maintain, your quality management system to support you in demonstrating ongoing regulatory compliance.

Step 3: Technical Documentation/Design Dossier/Technical File – Manufacturers must develop and maintain technical documentation for their medical devices. KD&A has the experience and skills to develop compliant technical documentation that describes the performance and safety requirements of your device. This is a key component of gaining regulatory certification.

Step 4: Conformity Assessment and Product Certification – KD&A can assist you to successfully work through the TGA and/or CE marking conformity assessment process including the examination of technical documentation and quality management system audits. KD&A provides critical initial and ongoing support. Our guidance throughout the process ensures you achieve and maintain device certification.

Visit www.kdas.com.au for more information about how we can assist you. Feel free to contact us if you have any questions. We can provide a detailed quotation specifically designed for your medical device inclusion in the Australian Register of Therapeutic Goods (ARTG) process and/or regulatory requirements specific to your organisation. Please contact us via email (kdent@kdas.com.au) or phone (+61 4 11 101 392).