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ISO 13485 vs IEC 62304: What Your Software Vendor Must Prove for Class II Medical Device Compliance

ISO 13485 vs IEC 62304: What Your Software Vendor Must Prove for Class II Medical Device Compliance

by Diana Balanoiu Panaite | Sep 17, 2026 | medical software

When your Class II medical device includes software, your software vendor’s quality system doesn’t just support your product, it becomes part of your FDA regulatory filing. The difference between a smooth 510(k) clearance and a months-long delay often...
Who’s legally liable when your software vendor touches PHI?

Who’s legally liable when your software vendor touches PHI?

by Diana Balanoiu Panaite | Sep 10, 2026 | BioTech, healthcare

Who’s legally liable when your software vendor touches PHI? The call that changes everything It’s 2:17 AM on a Saturday when your phone rings. On the other end: your security lead, voice tight. “One of our vendors just confirmed a breach. They’re not sure how many...
How detection improves cybersecurity R&D

How detection improves cybersecurity R&D

by Diana Balanoiu Panaite | Sep 3, 2026 | Uncategorized

At Areus, we often say: if you want to understand how serious a team is about security, don’t ask about their tools. Ask what they do when something almost breaks. This post is a story about one of those “almost” moments and how building better detection changed not...
How much can FinOps reduce cloud infrastructure costs?

How much can FinOps reduce cloud infrastructure costs?

by Diana Balanoiu Panaite | Aug 25, 2026 | Cloud Computing

For infrastructure modernizers, the question is rarely “Can FinOps save money?” and almost always “How much, how fast, and with what trade‑offs?” Industry data and real implementations point to a clear range: most organizations that formalize FinOps see 20–35% ongoing...
How does an extended engineering team work for SaaS scale-up?

How does an extended engineering team work for SaaS scale-up?

by Diana Balanoiu Panaite | Aug 18, 2026 | Software Development

How does an extended engineering team work for SaaS scale-up?  A SaaS company can gain thousands of users quickly. But behind every successful growth story is a difficult question:   Can the engineering team scale at the same speed as the product and customer...
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