Application lifecycle management (ALM) is no longer a solution that decision makers can ignore as part of their development plans.
Utilizing three core principles – collaboration, traceability, and workflow – it’s become easier to pass audits, compliance checks, and regulatory inspections using traceability that is easily implemented.
The Internet of Things (IoT) is changing how your business develops, manufactures, and supports products.
Software continues to “eat the world,” and our dependency on software continues to evolve, so there’s time for teams to suffer from rework and delays. Closing the gap between application lifecycle management (ALM) and product lifecycle management (PLM) gives your workers improved toolsets to implement during the development lifecycle. Read the rest of this entry »
In our previous blogs I described [blog 1] and [blog 2] the regulatory requirements related to product risk and the elements required to build a database for use in the risk management system. The following is a discussion of the risk management data model and how the evaluation of risk can be accomplished using the design control previously discussed.
ISO 14971 Annex E characterizes the relationship between elements in the analysis of risk with the following flow chart:
Organizations have the ability to bridge the gap between application lifecycle management (ALM) and product lifecycle management (PLM) – with proper ALM-PLM integration providing immediate business implications.
ALM-PLM integration provides the following benefits: Visibility across all assets, accurately link firmware with hardware, and collaboration and traceability of assets throughout all lifecycle phases. Engineers will not be overwhelmed by irrelevant data, as they are able to work in a domain familiar to them. Visit the ALM-PLM page by clicking here.
To view Business Benefits of ALM-PLM Integration on-demand, please click the following banner:
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.