Press Release, February 27th 2018       

Zurich, Switzerland. – As of today, PEDCO announces the partnership with Softcomply (www.softcomply.com). 

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 their tools and knowledge in order to achieve full product compliance for  Applied SAFe customers in medical device development.

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. With SoftComply Risk Manager, a JIRA add-on,  medical device developers are able to link risk management activities to their software development lifecycle and requirements, automate reporting and traceability. SoftComply automates regulatory compliance and integrates it to the agile software development environment ensuring the safety and compliance of medical device innovations. People from SoftComply are known to our product Applied SAFe and we at PEDCO are convinced, that the combination of our two products, a complete implementation of SAFe as a process model and SoftComply’s mechanics and pre-filled out templates, boosts scaled agility in the medical device development in order to bring a new product completely to market in a very short time.

This collaboration supports our commitment to foster scaled agility on an enterprise level, especially for companies working in a regulated environment. Applied SAFe is our fully-fledged implementation of the Scaled Agile Framework (SAFe) as a process model. Applied SAFe is based on and kept in sync with the actual SAFe version by Scaled Agile Inc. (SAI). Our product is officially approved by Scaled Agile Inc, the inventors of the Scaled Agile Framework. Implemented as a comprehensive, executable process model it includes all roles, activities, templates, guidelines, milestones, and phases in order to bring the framework to life; including metrics and tailoring. Applied SAFe is a ‘ready to go with’ implementation and allows organizations to start using the framework immediately.

For further information or requesting an online web-presentation please visit our website on www.appliedSAFe.com or get in contact with us on appliedSAFe@pedco.eu.

„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 still meets all regulatory requirements but also have a very performant tool to support a sustainable SAFe implementation. Together with our products, customers will almost immediately be able to develop medical device products.”

Dr. Marion Lempets, Managing Partner, SoftComply

„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 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, CEO, PEDCO

It is exciting to see PEDCO’s Applied SAFe come to life as a sophisticated, enterprise-ready solution for organizations wanting to adapt SAFe to their context and accelerate better business outcomes. We are extremely pleased to be partnering with the outstanding innovators at PEDCO on this important contribution to the SAFe community. The potential to help ease the way for fully comprehensive SAFe adoption is enormous.

Michael Stump, VP, Global Partner Development & Enablement, Scaled Agile Inc.

About SoftComply

SoftComply aims to speed up the regulatory compliance of medical devices so that the innovative products can be placed on the market faster and cheaper. To that end, SoftComply automates regulatory compliance and integrates it to the agile software development environment ensuring the safety and compliance of medical device innovations.

SoftComply offers Atlassian add-ons for medical device and other regulated industries: 1) SoftComply Risk Manager is an add-on for Jira that automates product risk management and integrates it to the software development environment for full traceability; 2) SoftComply eQMS to kickstart medical device quality system documentation as an add-on for Confluence.

SoftComply’s regulatory compliance software solution speeds up medical device CE-marking and FDA approval process while cutting compliance costs by 10 times! For more information, please visit our site: https://softcomply.com

About PEDCO

PEDCO – Managed Process Services is a public limited company based in Zurich, Switzerland and collaboration partner of Scaled Agile Inc., Boulder (USA) and Method Park, Erlangen (Germany). We support enterprises around the globe for process implementations within regulatory environments. We offer a comprehensive range of solutions to set-up, select, operate, and develop lean, compliant and efficient processes.

Our 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® is a stand-alone product from PEDCO. It is a fully fledged ALM tool agnostic implementation of the Scaled Agile Framework (SAFe®) as a process model and kept in sync with the actual SAFe® version by Scaled Agile Inc. (SAI). Together with our partners, we ensure a smooth transition to agile, lean, efficient and compliant processes with Applied SAFe.

PEDCO – Compliance and efficiency for your processes