Quality is an Accelerator: How Combined Modern ALM and QMS Software Speeds Up Product Development

Rami.Azulay June 6th, 2017 Posted by Rami Azulay( ) Software Lifecycle Management

By: Rami Azulay | ALM Master at ORCANOS

We are facing an ever-changing and increasingly complex medical device regulations, most companies I have been working with have built their compliance systems on risky paper-based quality systems as well their R&D legacy or in other cases general purpose software which is not built for med device.

Now is your chance to lead your organization to the next level. You can do better and we’ll can tell you how to do it by just spending 1 hour meeting with us. Go register now for free on http://www.orcanos.com/signup and ask from us to demo ORCANOS solution.

You already know by now that Inefficient systems increase your risk of noncompliance and increase your development time. That translates into your lake of ability to act quickly when quality event comes into your organization and to overwhelming spending of time and effort to manage that. In other cases we talk about missed sales opportunities and patients waiting longer for your new medical technologies.

So we’ll show you a modern, purpose-built software ORCANOS | MEDICAL that guide you step by step to ensures compliance with all the latest regulations to free up your engineers’ time, reduce risk, time to market, and help you pass audits with peaceful mind, since you know that you are under control..

In this one on one session, you can meet with ORCANOS. We’ll explain how innovative medical device manufacturers are leveraging modern R&D and QMS in one Software system to:

  • Accelerate product development efforts — from napkin idea using ORCANOS | ALM, to CE, 510K approval to market release months or years quicker
  • To Post Market support with end to end traceability between COMPLAINT to CAPA to ACTIONS to RESOLUTION back to the CUSTOMER with RISK mitigation.
  • Manage risk to drive the safety and quality of products and processes through QMS per ISO 13485:2016 & ISO 14971 and 21 CFR Part 820
  • Change their company’s focus from simply meeting regulations to building quality into their processes as a differentiator using real time compliance engine that measure your work against best practice quality KPI’s or your can design your own.
  • Understand and stay ahead of the FDA and EU changing quality regulations as leaders instead of followers using ORCANOS next gen Market Place (2018)

Setup time to meet with us by just register to our free evaluation on: http://www.orcanos.com/signup

 


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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