KD&A – How Can We Help you in 2014?
KD&A provide expert medical device and IVD regulatory guidance to help launch products and access new markets. Our services include regulatory strategy, product registration for Australian (TGA), EU (CE Marking), United States (FDA) and Canadian markets, as well as ISO and GMP quality system compliance.
Development of a sound regulatory strategy is an essential starting point for medical device and IVD manufacturers. Designed to provide your organisation with an understanding of specific regulatory requirements in chosen target markets, a Regulatory Strategy Report is your road map to market.
Quality Management System Development, Implementation and Support
Any Australian manufacturer of a medical device or IVD higher than a Class I must have a Quality Management System. These systems are required by regulators in most regions because they define and control how medical products are developed, documented, released, modified, manufactured, traced, maintained, and also recalled.
Technical File or Design Dossier
For all medical device and IVD manufacturers, a key component of gaining regulatory approval is technical documentation. This documentation, incorporates a large amount of product information and can be time consuming and difficult to compile. The documentation describes your device and records how your organisation demonstrates compliance with applicable regulatory requirements (including selection and compliance with standards).
The Therapeutic Goods Administration (TGA) requires that all medical devices and IVDs sold in Australia be included on the Australian Register for Therapeutic Goods (ARTG). This is known formally as ARTG inclusion or TGA certification, but also as product registration or product listing.
Post Market Surveillance Systems
It is a requirement that all medical devices and IVDs included on the ARTG be monitored whilst on the Australian market. Post-market monitoring is a combination of proactive and reactive actions, and is a mandatory regulatory requirement. KD&A’s Post-Market Surveillance Systems are designed to guide your organisation in the process of completing post-market actions such as product reporting, recall, and review.
TGA Conformity Assessment (manufacturers)
Australian medical device and IVD manufacturers must obtain and maintain Therapeutic Goods Administration (TGA) certification in order to manufacture devices in Australia. Initially this process includes a Conformity Assessment Application and audit by the TGA. KD&A can assist you to most effectively demonstrate compliance with TGA requirements. We have 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 to discuss your project or to obtain a personalised quotation.