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.Schedule Demo
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.