RCM COMPLIANCE
Compliance Folder Management, EMC/RF RCM Declaration of Conformity (DoC)
24
Oct
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
SEARCH FOR A CERTIFICATE
23
Oct
SUBMIT A FEEDBACK FORM
23
Oct
REQUEST A QUOTATION
23
Oct