KD&A

Regulatory Advice for Medical Device and IVD Companies

Call us today +61 8 8271 2347

Product Registration »

Trouble free Australian Register for Therapeutic Goods (ARTG) Inclusion to enable Australian sales for all classes of devices.

Regulatory Strategy »

Anticipate regulatory requirements and map your road to market with a Regulatory Strategy report that defines the essential steps.

Quality Management System »

A QMS that supports your business and meets regulatory requirements, developed by pragmatic and experts who understand the challenge from both company and auditor perspectives.

Technical Documentation »

A pragmatic approach to technical documentation to meet regulatory requirements for Australian TGA certification, European Union CE Marking, and any other target market.

TGA Conformity Assessment »

Expert guidance through the conformity assessment process from application and audit, through to full compliance.

Post-Market Surveillance »

KD&A’s Post-Market Surveillance systems are designed to guide your organisation in essential post-market actions such as product development and product recall.

Promotional Materials Review »

Avoid serious consequences by understanding how to promote your products while maintaining compliance with the Australian Therapeutic Goods Advertising Code (TGAC).

Expert medical device and IVD regulatory guidance to help launch products and access new markets.

Services include: product registration for Australian (TGA), EU (CE Marking), United States (FDA) and Canadian markets, as well as ISO and GMP quality system compliance.