What we do
KD&A specialises in providing an extensive range of business and regulatory services to manufacturers of medical devices and in vitro diagnostics, sponsors and other organisations. Some of these services include:
  • Regulatory Advice
  • Technical Documentation
  • Assistance with Quality System Certification
  • Exporting Assistance

'KD&A provides its services by looking at the big picture – not just the regulatory issues. We understand that gaining regulatory approval is just one aspect of your business, thus KD&A offers complete business and regulatory solutions.' - quote by Managing Director, Kea Dent-Imgraben.

Our up-coming 2010 Medical Device Regulation Workshop

Why choose KD&A?
KD&A is different to other regulatory companies because we offer a full range of services meaning, we can take care of all your needs. Our services are based on over 15 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 and tailoring solutions to the needs of your company.

How can KD&A help your business?
Regulatory Advice
Need regulatory advice? KD&A has the specialised expertise required to support your business with any regulatory aspect of bringing your product to market. We also provide ongoing support to ensure your accreditations are effectively and successfully maintained. We can provide services to you on an ongoing or ‘as-needed’ basis, whatever is best for your company.

Technical Documentation
Need technical documentation? 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.

Quality Systems
Need ISO 13485 or AS/NZS 9001 certification? KD&A can provide the advice, support and documentation needed to obtain your desired quality certification.

Export Development Assistance
Need exporting assistance? With our vast exporting experience we can develop an export strategy tailored to your company’s unique needs.

Business Plans, Strategy and Development
Need help with ensuring that your business reaches its full potential? KD&A can provide a range of services to make your business more competitive.

Please contact us for a quotation or to discuss your needs. We look forward to hearing from you.