GEMS REGISTRATION
Energy efficiency report assessment and MEPS registration.
24
Oct
24
Oct
DUE DILIGENCE
Test reports, certificates and documentation assessment to minimize liability risks.
24
Oct
SAFETY CERTIFICATION
Certification of imported electrical medical devices to Australian safety standards AS/NZS 3200.1, AS/NZS IEC 60601.1
24
Oct
TGA REGISTRATION
Agent services for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG)
24
Oct
REGULATORY & QUALITY CONSULTING
- 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 for start-up MedTechs
- All risk classes medical devices including active implantables, Artificial Intelligence (AI) in Software as a Medical Device (SaMD)
- Regulatory strategy in key markets: EU, UK, US, Australia
- Technical File preparation
- 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 of medical devices
- Training sessions tailored to customer needs – category of devices, target market(s)
- Regulatory and quality workshops
23
Oct
GET IN CONTACT
23
Oct
CALL ON (02)9955662233
23
Oct