Subscribe to the SoftComply Blog
Stay connected with SoftComply and receive new blog posts in your inbox.
Marion Lepmets
Welcome to the wondrous world of GRC! Don’t worry, you’re not alone if GRC sounds like a magic spell from “Harry Potter.” For most of us, Governance, Risk, and Compliance (GRC) is one of those terms that sounds important in meetings, like when someone mentions “synergy.” But the truth is,...
Marion Lepmets
If your risk register lives in a spreadsheet, chances are it’s already failing you – even if it looks fine. It was probably created with great intentions at a project kickoff meeting as something every good project manager should do. It might even get reviewed once a quarter (on a...
Marion Lepmets
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...
Marion Lepmets
If you’re an Atlassian Marketplace app vendor or you’re exploring how to bring AI capabilities like Rovo into your products and services, this article is for you. AI is no longer optional – and neither is compliance. What used to be the domain of a few highly regulated sectors like...
Marion Lepmets
Is your organization struggling to keep up with crucial information security (InfoSec) management requirements? Today, every company faces a constant stream of threats, from ransomware and phishing to third-party vulnerabilities. In response, an increasing number of companies are standardizing their InfoSec efforts by following frameworks like ISO 27001 or SOC...
Marion Lepmets
If you’re developing a medical device, you must prove that it is safe and effective. That proof lives in your documents: your procedures, design records, risk assessments, and test reports. Managing those documents properly is called “document control”. At first, this might sound like an administrative detail — a few...
