Medical Device

The challenge

It is no secret that medical device companies incur high costs and organizational stress relating to creating and maintaining their technical file, DHF or ISO documentation, especially before first time submission or external auditing by notified bodies.

There are many consulting companies that help companies generate the needed deliverables, but without the needed tools and processes the documents are only documents and don’t really represent the way the organisation operates. Managing two separate companies, one in the documentation and one in real-life operations is an almost impossible task. The alternative of maintaining sometimes hundreds of cross referenced documents for every aspect of the company is also rarely practical in today’s economy, where every resource is pushed to its limit.

Fast ROI – implementing QPack Medical will add typically 3-4% to your production budget on the first year, but our case studies show that from year two, our customers are reporting above 40% of efficiency increase and cost reduction for the administration of the development, risk and V&V processes. 

Orcanos solution

Warranting Successful Medical Device Auditing and Regulatory Compliance through Process Automation Tools

Orcanos is an Israeli software vendor that provides Orcanos Medical™ software solutions for  regulatory compliance and safety traceability and is designed for medical device manufacturers. Orcanos has more than 8 years of experience in a regulated hi-tech industry, working with medical device companies and assisting them in building their operational excellence.  While moving 80% of the manual paperwork into a process automation tool, Orcanos ensures readiness for CE, FDA submission and audits.

Orcanos solutions are already implemented in medical device companies, such as Mazor Robotics, Rewalk, Haldor, EBS Tech and more.

Orcanos Medical™ System

Orcanos Medical provides an up-to-date set of DHF electronic records with complete traceability ready for audit on demand. Furthermore, as Orcanos Medical reflects your regulatory compliance map, it becomes obvious where there are inconsistencies, anomalies and missing items. This way, Orcanos Medical makes sure nothing falls between the cracks.

Orcanos Medical fully controls and maintains the traceability of DHF items, such as risks, test cases, test results, market/product/system requirements, software/hardware / mechanical requirements, CAPA/CAR, complaints, meeting summaries, design reviews, action items, defects, training programs, safety and much more while capturing the complete R&D process. Orcanos Medical also manages all validation and verification activities. The Orcanos solution satisfies acceptable industry standards, such as ISO 14971ISO 13485IEC 62304 and more.

By turning Orcanos and the DHF file into your company’s backbone management process, you ensure your business objectives and reduce operational risk. The Orcanos Medical tool emphasizes traceability and risk management. We have inconsistencies filters and alerts that guard your organization from unmitigated risks. We also monitor SRS without traceability, critical tests that have failed and customer complaint without CAPA.



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