Regulatory Affairs

Regulatory affairs services are critical to a medical device’s product lifecycle and therefore specialist advice must be sought before, during and after the launch of a new device. Every company that innovates in this arena seeks to offer a more effective treatment to a particular condition or disease and improve patient outcomes; therefore it’s vital that compliance and regulatory affairs responsibilities are taken seriously.
We offer the following regulatory affairs services:

• Definition of a regulatory strategy for local or global markets including pre-market strategy, regulatory submissions and post-market compliance.
• EU registration – we will compile technical files for your product to comply with MDD/MDR requirements.
• TGA (Therapeutic Goods Administration) registration – the TGA is a unit of the Australian Government’s Department of Health and Aging which oversees medical device regulation in Australia.
• Review of marketing materials for compliance based on region-related regulatory requirements.
• Transition from MDD to MDR