To read the first blog in this series, Comprehensive Medical Device Risk Management, please click here.
The first task of any product development process is generally to discover, define and link the items of interest for that product. This is best accomplished in a logic Flow Diagram, and is the basis for developing the Design V&V test plan, and risk Management framework. One example of such a diagram is the Polarion medical device template comprehensive traceability table (shown below).
One of the more difficult system development tasks in the context of a new medical device is how to organize and develop the product risk management strategy. When contemplating how to construct a system to manage this task, it’s necessary to consult not only company work flows and processes, but standards adopted by the competent authorities meant to standardize how medical device products are developed and approved.
At the time of this writing, the two standards used in definition and implementation of medical device risk management are ISO 14971:2009 and TIR 24971:2013. Europe has added to the mix by approving an EN ISO version of 14971, which is EN ISO 14971:2012. The EN version is different in several important aspects, and is required if the company is selling into Europe. Read the rest of this entry »
Adopting Enterprise Agile can be a tough decision, as there is even more competition in the enterprise business world. As your development team needs to deliver better software – at an even faster pace – it’s a topic that we’ve discussed with you in the past.
It’s no longer just individual departments embracing agile software development, with companies showing increased interest in Enterprise Agile. Is your organization ready? We recently hosted a webinar that discusses some of the benefits – and challenges – related to Enterprise Agile.
During the recorded webinar, you’ll hear an introduction about Enterprise Agile and Polarion, lessons learned about the transition, and recommendations for better rollout. Click the following banner to download:
One of the things I always enjoy about my role is getting to showcase the latest output of our stellar development team. In the new version just released, Polarion 2016 SR1, we have focused less on introducing new features and more on enhancement of existing features, especially in Test Management and LiveDocs. We also put a lot of efforts into things around performance and scalability – something we will continue to do. So with that in mind, let’s jump in and see what’s in this release. Read the rest of this entry »
Software has evolved to become the key differentiator for medical device manufacturers, even though there are continued challenges.
The use of a unified application lifecycle management (ALM) solution, such as Polarion ALM, accelerates innovation while at the same time streamlining quality assurance and automating proof of compliance.
Despite the benefits of software innovation for medical devices, there are a number of strict quality requirements, product failure risks, and even more regulatory complexity.
The successful adoption of application lifecycle management (ALM) [Polarion ALM] and product lifecycle management (PLM) has given Siemens the last major piece to its “systems-driven product development environment” – as IoT leads to even more connected medical devices, cars, factories, and other emerging solutions.
The parallel silos formed around ALM and PLM solutions have come crashing down with better supported ALM-PLM integration. In the past, we discussed a unified ALM-PLM roadmap with a future vision, strategy, and steps toward success.
On behalf of Polarion Software, I hope you had a wonderful and safe Memorial Day Weekend. It’s been an extremely busy 2016 for Polarion Software, as we continue to host webinars, create white papers, and share knowledge regarding our solutions.
Organizations now face even tougher competition, forcing enterprise developers to rapidly create – and support – innovative software. Following the agile methodology provides better software at a faster pace, but embracing Enterprise Agile can be an extremely difficult process.
To learn more, we invite you to an upcoming webinar hosted by Jiri Walek, Vice President of Product Management of Polarion Software.
Polarion Software looks forward to providing professional services and expertise to SmartFactoryOWL, an initiative of the Fraunhofer-Society and the OWL University of Applied Sciences.
Working to support the “DiMan” research program, we will support the project for two years – as researchers look to integrate and adjust hardware and software development processes in the Industry 4.0 era.
Millions of connected cars are hitting the roads each year, but cybersecurity remains a puzzling problem facing automakers, tech companies, and OEMs.
Auto buyers enjoy mobile connectivity, but trying to keep all of these emerging services secure is extremely difficult. To help discuss some of the challenges, and current solutions available, Polarion Software would like to invite you to the following webinar: “Cyber security for the connected car.”
The webinar takes place on:
Wednesday, May 18 @ 11:00 AM (8 AM PST). It’s a free 60-minute webinar, featuring Polarion Software’s Mike Borse, in addition to three other industry experts.
The adoption of software is a new complexity that is forcing many organizations straight into a sink or swim scenario, as it’s an emerging experience for manufacturers. Industries don’t have a choice, as they must navigate these new challenges, or risk being left behind by competitors.
In the past, it wasn’t uncommon that management of product development and software development processes were siloed away from one another.
Polarion Software has been listed as a “Market Leader” in two separate categories by the Ovum analyst group, a great honor after being compared to numerous other vendors.
As a market leader in both the Application Lifecycle Management Solution Report and Agile Project Management Solution Report, Polarion ALM [visit the Polarion ALM page] provides support for the complete software development lifecycle – from requirements management up to build and release management.
Organizations discover that a lack of a proper lifecycle management process can disrupt work, waste valuable manpower, and ultimately push back development time. Read the rest of this entry »