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