Orcanos
Combined eQMS and ALM platform for medical device compliance, design control and traceability
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Sign in to write a reviewSmall, mid-size and large organizations in Healthcare, Pharmaceuticals across 2 countries.
What is Orcanos?
Orcanos is an Israeli software company, based in Givatayim with a US office in New Jersey, that combines an electronic quality management system with application lifecycle management for medical device makers. The platform links document control, training, CAPA, nonconformance, complaints and risk management with requirements, test and defect management, so design history files and traceability can be compiled for ISO 13485, EU MDR and FDA 21 CFR Part 11 work. The company says more than 100 medtech companies use the product, from early-stage startups to established manufacturers, and cites an average go-live of about 24 days.
Services and products
- Document control
- CAPA and nonconformance management
- Training management
- Risk management (ISO 14971)
- Requirements and test management
- Traceability and DHF compilation
- Complaint handling
Based on the company's website. The company can claim this page to update it.
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