What is Software as a Medical Device (SaMD)?Software as a Medical Device (SaMD) is software intended to perform medical functions independently of a physical medical device. This includes mobile apps, AI diagnostic platforms, and cloud-based monitoring systems that diagnose, treat, or prevent diseases. Let’s explore the essentials of SaMD development, focusing on key concepts, challenges, […]
What is SOX compliance and why does it matter?SOX compliance refers to adhering to the Sarbanes-Oxley Act of 2002, a U.S. law requiring public companies to maintain accurate financial reporting and strong internal controls. Non-compliance can lead to severe penalties, reputational damage, and executive liability. SOX Compliance is all about following the rules set by […]
The HITECH (Health Information Technology for Economic and Clinical Health) Act has changed how healthcare providers handle patient information by promoting the use of Electronic Health Records (EHR) and creating a strong compliance framework. A key part of this framework is the audit process, which ensures that healthcare organizations follow HIPAA’s rules on privacy, security, […]
Hey there! Let’s talk about PCI DSS Audit. It’s a big deal for anyone dealing with credit card info. What is PCI DSS and why is it important?PCI DSS (Payment Card Industry Data Security Standard) is a global security standard designed to protect cardholder data. It applies to any organization that stores, processes, or transmits […]
SOC (Service Organization Control) audits are a way to show that your internal processes are up to standard—whether it’s managing financial data or protecting sensitive information like customer privacy. SOC 2 compliance is a set of guidelines that helps companies manage and protect customer data. It’s especially important for businesses that offer services to other […]
Navigating the HealthTech or MedTech landscape can be complex, especially with numerous challenges and regulations. The right DevOps partner can help you move faster, ensure data privacy, and scale your product sustainably. The wrong one? That could mean downtime, HIPAA violations, and massive fines. So, how do you choose wisely, especially when you’re juggling product development, […]
