July 2017 Posts

Using Agile in a Regulated Environment

Using Agile in a Regulated Environment

Stanley Curtis, Chief Technology Officer & Senior Vice President of Software Engineering, Pilgrim Quality Solutions

Recently, I was reviewing a MOOC (Massively Open Online Course) that teaches how to use Agile methodology in the development of SaaS (Software as a Service) products. This is a great scenario for the Agile SDLC (Software Development Lifecycle) since SaaS solutions typically change on a frequent basis as new features are added, or defects are fixed and released on a defined and regular schedule that fit into one or more sprints that range in length from 1-4 weeks. As there are changes, the software is updated and pushed to production to meet new or changing market requirements. If you read the textbooks about Agile, what I just described fits the Agile narrative very closely.
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EU Medical Device Regulations: Changes on the Horizon

EU Medical Device Regulations: Changes on the Horizon

Cynthia Lambert, Regulatory and Industry Specialist, Pilgrim Quality Solutions

There are significant changes on the regulatory horizon in Europe due to the publication of the new European Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), which were approved by the European Parliament on April 5, 2017. The industry is now subject to a three-year transition period for compliance among medical devices, and a five-year period for compliance among in vitro diagnostic (IVD) products.
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The Case for Cloud: Why Regulated Industries Should Pay Attention!

The Case for Cloud: Why Regulated Industries Should Pay Attention!

Kumud Bhattarai, Director of Software Development & Enterprise Architect, Pilgrim Quality Solutions

Cloud computing can be loosely defined as the process by which a set of data resources are housed somewhere remote and are accessed using the Internet. Traditionally, these resources have been housed inside the data owner’s own office building behind a firewall, providing very limited or no access from the outside, and thereby, protecting these resources from outside intrusion. But the pendulum is swinging again. Forty years ago it was in the form of time-share computing. Today, in the global marketplace, an increasing number of organizations are opting to move to the Cloud – which in many respects is today’s time-share computing environment, only faster, cheaper, highly secure, reliable, and more accessible.
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Key Takeaways: Choosing the Right QMS for ISO 13485:2016 Compliance

Key Takeaways: Choosing the Right QMS for ISO 13485:2016 Compliance

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

Last week, we hosted a webinar titled “Choosing the Right Quality Management Solution (QMS) for ISO 13485:2016 Compliance.” During the presentation, we provided a brief overview of changes to the updated regulation, details on certification timing, and a demonstration of how Pilgrim’s SmartSolve® quality management software simplifies compliance with the new version of the standard. If you missed the live session, you can view the on-demand version of our ISO 13485:2016 solution webinar here.
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