Founded in 2005, Orcanos Software has built its reputation on delivering integrated solutions that ease the time-to-market product hurdles that are part of the Quality Journey. In fact, Orcanos is the only vendor that provides an integrated software solution for Application Lifecycle Management (ALM, aka Design Control) and Quality Management Systems (QMS), that includes regulatory compliance, with a specialized focus on the medical device industry.
As a result Orcanos has years of proven experience and innovation in a regulated and increasingly high-tech industry. Our team has honed their skills by working with medical device manufacturers and other high-tech companies, not only assisting them in building their operational excellence capabilities but also ensuring that the product lifecycle proceeds on a smooth path from day one.
Orcanos’ research and development centers build and enhance the Orcanos software, based on the inputs received from our growing customer base. This ensures that medical device companies are prepared for the EU’s Conformite Europeenne (CE) Mark, MDSAP, FDA submission and potential audits, and any associated operational costs or risk management issues.
Paper-based processes have become chokepoints for many companies, and we have dedicated ourselves to a more streamlined process which shifts 80 percent of the manually generated paperwork into a process automation tool. By doing this, we can help our customers implement their business optimization processes and methodologies.
Our vast experience and expertise has given us the ability to provide tailor-made and custom solutions to medical device companies of all sizes. Additionally, the integrated ALM and QMS solution that we offer sets Orcanos apart from other quality management vendors and consultants in what is a highly competitive marketplace.
We believe that our solution is a perfect fit for the Life Science industry, especially medical device manufacturers of all sizes, and our customer base ranges from global brands to SMBs. Successful products rely on quality to achieve their goals, an aspirational goal that dovetails with our desire to make the journey as painless as possible.
To date, Orcanos’ medical device customers have been able to improve productivity and product quality, streamline compliance with regulations such as ISO 13485, IEC 62304 and ISO 14971, better comply effectively with regulatory authorities such as FDA and CE. And by using Orcanos smart dashboards and real-time alerts, our customers not only keep track of their ongoing projects but also have real-time visibility on a product’s progress along its quality journey.
Interested in learning more? Schedule a demo today!