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?

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’.

The changes, which amend the Therapeutic Goods (Medical Devices) Regulations 2002, are designed to modernise Australia’s medical device regulatory framework. Some of the notable changes include:

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.

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.

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.

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.