TGA requires that all medical devices whether Class I, Class II or Class III must meet the necessary conformity assessment procedure. If you are a manufacturer of medical devices, you must have the appropriate quality management system like ISO 13485 and, where needed, a TGA conformity assessment certificate.
R2 Pharma Solutions can help manufacturers, sponsors and distributors comply with all medical device regulations. For sponsors, we can assist in designing the necessary quality management systems and provide training to meet sponsor obligations.
Our medical device experts can design the quality management system in accordance with ISO 13485. We can perform the gap analysis between your current system and assist with any necessary changes required to achieve ISO 13485 certification.
