Quality Management System procedures development

In compliance with ISO 13485, EU MDR, FDA 21 CFR Part 820 (QSR) and TGA regulations.

Pre- and post-market regulatory compliance

Pre- and post-market regulatory compliance for start-up medical device companies.

Regulatory compliance

Regulatory compliance for all risk classes medical devices, including active implantables, Artificial Intelligence (AI) in Software as a Medical Device (SaMD).

Regulatory strategy

Regulatory strategy in key markets: EU, UK, US, Australia.

Technical File

Technical File preparation.

Regulatory submissions

Regulatory submissions to EU Notified Body, FDA 510(k)s and PMAs, inclusion in the TGA ARTG.

Unique Device Identification (UDI)

Risk management

Clinical evaluation

Advertising

Advertising of medical devices.