How SoftComply and Eficode helped Cobham Satcom Build a Scalable Risk Management Framework in Jira
Implementing risk management in highly regulated industries isn’t just about passing audits – it’s about creating processes that scale across the business. That was exactly the challenge facing Cobham Satcom, a leading provider of satellite communication solutions for the regulated industries. Working together, SoftComply and Eficode combined product expertise with Atlassian consulting to deliver a […]
Frictionless Information Security Management in Jira
What if your next ISO 27001 audit required almost no preparation? That’s exactly how Lemuel Valdez, CISO at Cobham Satcom, approaches security. Instead of scrambling to collect evidence before an audit, he builds systems where audit readiness is simply a byproduct of everyday work. “Controls, risk approvals, documents and evidence are linked in a system […]
Achieving CE Mark Faster: Amiko’s Story of Agile Compliance with a Confluence-Based Document Management System
We recently sat down with Elisa Lo Blanco, Quality Assurance and Regulatory Affairs Manager at Amiko, a digital health company focused on chronic respiratory conditions, to discuss their journey to achieving CE marking under the Medical Device Regulation (MDR). Amiko’s success highlights how MedTech startups can balance the need for regulatory rigor with the flexibility […]
Doccle: How an Integrated Risk Management System paved the road to ISO27001 compliance
Doccle, a leading IT service provider in Belgium that specializes in helping businesses transition to 100% digital invoice administration realized that one of their own central processes – risk management – was not yet fully digitalized. They started a search for an integrated, efficient, and compliance-ready risk management solution within their existing Jira and Confluence […]
How a Compliance Solution on Atlassian Cloud Empowered a Leading MedTech Company
A mid-sized company in the medical technology sector faced a growing challenge: meeting the stringent requirements of the Medical Device Regulation (MDR) and FDA 21 CFR. As the company expanded, the existing ways of managing risks and documentation – such as Excel spreadsheets and paper-based processes – became increasingly inefficient and error-prone. This not only […]
Navigating FDA Cybersecurity Requirements for Medical Devices – A Case Study
This case study describes the experience of a multinational medical device manufacturer meeting the FDA cybersecurity requirements. The company is operating in the MedTech sector developing a class 2/IIb device consisting of hardware and software. The company spent about 2 years working on the security risk management of the device. In addition, they also embarked […]
How Can ISO 27001 Certificate Boost your Sales: Case Study of Ocumetra
On February 1, 2024 SoftComply held a webinar on Data Privacy and Security where Ocumetra shared their experience on preparing for and attaining the ISO 27001 certificate. Following is a summary of questions asked and answers provided – full case study can be viewed also in the YouTube video. Ocumetra is an Irish company that […]
Agile eQMS to Move Faster & Break Nothing
Our customer Orthogonal describes how to set up an agile eQMS solution on Atlassian Confluence and Jira
In Search of a Compliance Solution that Lets You Sleep at Night
How to find the best regulatory compliance solution for medtech on Atlassian
Compliance of myBioma
The Regulatory Compliance Journey of myBioma Biome Diagnostics GmbH is an Austrian medtech start-up utilizing the genetic information of the microbiome and AI to develop medical diagnostic software for doctors. Biome Dx products utilize technologies such as next-generation sequencing, pipeline architectures and microservices. With their lifestyle product myBioma every European has the possibility to learn […]
