TGA Conformity Assessment / CE Marking

KD&A can assist you to successfully work through the TGA and/or CE Marking Conformity Assessment Processes. 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.

KD&A, as an expert medical device consultant, has significant experience with the TGA, and the Conformity Assessment process – we are ready to guide you efficiently through application and audit, to full compliance.

Contact us if you require a custom quote.

Have a few questions? Visit our Frequently Asked Questions page.

KD&A can assist you to most effectively demonstrate compliance with Australian (TGA) and/or European requirements