REGULATORY CONSULTING SERVICES TO HELP YOU LAUNCH PRODUCTS AND ACCESS NEW MARKETS

As expert medical device consultants, KD&A provides you with sound regulatory advice that will save you money and time as you prepare medical devices and IVDs for market launch. KD&A will help you understand early on which regulatory requirements apply, so you can plan ahead to meet requirements cost-effectively and with minimal disruption.

KD&A specialise in providing a range of medical device regulatory services to manufacturers, sponsors, and distributors of medical devices and IVD devices. These services include:

• Medical device regulatory strategy report and roadmap to market.
• ISO 13485 QMS development, maintenance, internal auditing and support including regulator/ Notified Body audits.
• Global medical device registrations; EU CE Marking, Australia TGA Conformity Assessment and Australian Register of Therapeutic Goods (ARTG) inclusions, US FDA, Health Canada, UK UKCA, Singapore HSA, etc.
• Development of device specific Technical File documentation for medical devices and IVD devices.
• TGA sponsor.
• Post market surveillance including reporting to the TGA.

With over three decades of experience in the medical device sector, Kea possesses a wealth of expertise, having worked as both a medical device manufacturer and regulatory consultant

Our vast understanding of the medical device regulations across the different markets ensures you receive the most accurate and up to date information for your medical and IVD devices.

To learn more, read what some of our customers say about us.

Have a few questions? Visit our Frequently Asked Questions page.

For information on KD&A’s full range of services see below.

• Medical Device Regulatory Strategy
• ISO 13485/MDSAP QMS Development and Support
• Technical File Documentation
• Global Medical Device Registrations including ARTG Inclusions/TGA Registrations
• Post-Market Surveillance
• TGA Conformity Assessment/CE Marking
• Promotional Materials Review
• Australian TGA Sponsor
• Medical Device and IVD Device Classification Assessment
• Software as a Medical Device (SaMD)