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| KD & A |
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KD&A provides regulatory services that apply to the Australian and International Markets. For the Australian market we provide all advice regarding the Therapeutic Goods Administration. In International markets we provide highly specialised advice for the achievement of the CE Mark (European Union). Further experience will assist your company in gaining regulatory certifications in many countries include the following Canada (Health Canada) and the USA (Food & Drug Administration).
Certain regulatory certifications require the creation of technical documentation. This documentation, known as a Technical File, incorporates a huge amount of product information and can be extremely time consuming and difficult to put together. KD&A has the skills and experience needed to effectively and efficiently develop this documentation, leaving you with more time to focus on your business.
Need ISO 13485 or AS/NZS 9001 certification? KD&A can provide the advice, support and documentation needed to obtain your desired quality certification.
KD&A has the specialised expertise required to support businesses with any regulatory aspect of bringing a medical device to market. We also provide ongoing support to ensure accreditations are effectively and successfully maintained.
KD&A specialises in providing regulatory services for international and domestic markets. We provide a range of business services such as regulatory advice, technical documentation, quality systems and export development assistance.
KD&A is different to other regulatory companies because we offer a full range of services meaning, that we can take care of all your needs. Our services are based on over 12 years of experience within the medical device industry, both as a successful medical device manufacturing exporter, which exported to 44 countries, and as a regulatory specialist. As a result, we understand the importance of providing client focused services, tailoring solutions to the needs of your company.
www.kdas.com.au
 
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