Ora Innovations, Inc.
Consulting firm providing quality management, regulatory affairs, product development, product licensing and workplace health & safety services for medical device, pharmaceutical and other industries. Services include QMS implementation and training, regulatory pathway analysis and submissions support, technical documentation, product realisation and commercialisation support.
Industries
N/A
Nr. of Employees
small (1-50)
Services
QMS implementation, maintenance, training, certification advice, supplier evaluation and audits.
Regulatory path analysis, document preparation, representation and agent services for market registrations and submissions.
Design-to-manufacturing product development support including NPI, DHF/DMR/DHR, FMEA and process validation.
Provisional patent preparation, prototype support, sales sheet preparation, market research and licensing negotiation support.
Develop and implement WH&S systems, emergency evacuation planning and HAZCHEM/material handling guidance.
QMS implementation, maintenance, training, certification advice, supplier evaluation and audits.
Regulatory path analysis, document preparation, representation and agent services for market registrations and submissions.
Design-to-manufacturing product development support including NPI, DHF/DMR/DHR, FMEA and process validation.
Provisional patent preparation, prototype support, sales sheet preparation, market research and licensing negotiation support.
Develop and implement WH&S systems, emergency evacuation planning and HAZCHEM/material handling guidance.
Expertise Areas
- Quality management systems (ISO 13485, ISO 9001)
- Regulatory compliance and submissions (TGA, CE, FDA, CMDR, PMDA, SFDA)
- Medical device product development and new product introduction
- Product licensing and commercialization
Key Technologies
- ISO standards (ISO 13485, ISO 9001, ISO 27001, ISO 14001)
- Regulatory frameworks (TGA, CE/MDR, FDA QSR/510(k)/PMA, CMDR, PMDA, SFDA)
- Risk management (EN ISO 14971)
- Human factors / usability (EN ISO 62366)
News & Updates
Introductory blog post announcing website updates and new team members; mentions regulatory updates and team expertise.
Provided consulting services for multiple successful businesses across Australia; systems implemented commended by local and international certifying bodies.
Introductory blog post announcing website updates and new team members; mentions regulatory updates and team expertise.
Provided consulting services for multiple successful businesses across Australia; systems implemented commended by local and international certifying bodies.