Agility in Regulated Domains – Partnership between PEDCO and SoftComply

Dublin, Ireland on February 27, 2018

As of today, SoftComply announces the partnership with PEDCO .

PEDCO and SoftComply will work together in fostering the growing numbers of Applied SAFe customers; where PEDCO delivers its own product Applied SAFe® and SoftComply helps with our tools and knowledge in order to achieve full product compliance for Applied SAFe customers in the medical device domain.

PEDCO supports competitive enterprises in the efficient and successful implementation of demanding processes. PEDCO helps organizations in the set-up, selection, operation and further development of lean and effective processes. This allows to direct processes in compliance with the defined product and process guidelines, agile, efficiently and with transparent costs. PEDCO’s mission is to help system and software-dependent enterprises achieve better business outcomes, increase employee engagement, and improve economics through the application of Lean-Agile principles and practices with Applied SAFe® based on the Scaled Agile Framework® (SAFe®).

Applied SAFe – Agile is a new standard in the development paradigm and in the industry. The challenges of ‘Agile at Scale’ are realized every day. The only method out there for agility at scale is the Scaled Agile Framework. PEDCO believes that the Scaled Agile Framework is the de-facto standard for agility at scale. PEDCO has direct access to the thought leadership and all the content of SAFe, the Scaled Agile Framework, which is the de-facto standard for agility at scale. Combined with that we have access to Stages, the world leading process management tool and we as system integrators have integrated both the framework and the platform into one product called Applied SAFe.

Applied SAFe works for those organizations who are in highly complex, highly compliant and auditable organizations such as Automotive, Defense, Aerospace, Medical and Finance. These organizations depend on their process and their process authoring and being able to stand up in terms of an audit or against an audit. Applied SAFe from PEDCO creates a dynamic where you can author your entire process and instantiate to your community internal or external and ensure that you have the best and most compliant process for your organization.

SoftComply automates regulatory compliance and integrates it to the agile software development environment ensuring the safety and compliance of medical device innovations. One of the major challenges in developing software for regulated environments is ensuring the safety of the final product. SoftComply automates regulatory compliance and integrates it to the agile software development environment ensuring the safety and compliance of medical device innovations. People from PEDCO know SoftComply products well and we at SoftComply are convinced, that the combination of our two products, a complete implementation of SAFe as a process model and SoftComply’s automation of Risk Management and pre-filled templates for Quality Management System, boosts scaled agility in the medical device companies in order to bring a new product to market in a very short time.

Our collaboration supports our commitment to foster scaled agility on an enterprise level, especially for companies working in the regulated environment like the medical device domain.



“We are proud to find with SoftComply such an outstanding tool partner to collaborate with! It’s a pleasure to find a partner with such a comprehensive subject matter expertise in regulated and especially medical device development and using Attlassian tool based development. With the help of SoftComply’s tools we can support a fast start up for companies to ensures a smooth transition towards agile, lean and compliant processes for the growing numbers of global Applied SAFe customers..”

Peter Pedross, PEDCO AG – CEO & Founder


“Medical device companies are often overwhelmed with regulatory requirements for their complex devices. With Applied SAFe these companies can not only prove that the development of complex physical products using SAFe meets all regulatory requirements but also have a very powerful tool to support a sustainable SAFe implementation. Together with our products, customers will almost immediately be able to develop medical device products.”

Dr. Marion Lepmets, SoftComply – CEO & Co-Founder

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