FDA arkistot - Nometech Oy - Medical Device Regulatory & Quality Services

FDA Human Factors guidance document on a desk with a notebook, pen and Nometech business card.

FDA – Human Factors Validation

FDA’s 2026 Human Factors guidance clarifies what information should be included in medical device submissions. Here’s what changed, what the new HF Submission Categories mean, and why it matters.

FDA – Human Factors Validation Read More »

Implantable medical device components and technical documentation on a desk representing MDR and FDA regulatory compliance for implantable devices.

Navigating the Regulatory Landscape for Implantable Medical Devices

CE, EU MDR, FDA, QMS, QMSR, Regulatory

Implantable medical devices face some of the strictest regulatory requirements under MDR and FDA frameworks. This article explores clinical evaluation, PMCF, risk management, technical documentation, cybersecurity, and regulatory strategy for implantable medical devices.

Navigating the Regulatory Landscape for Implantable Medical Devices Read More »

Post-Market Surveillance dashboard showing real-world medical device data, analytics and performance monitoring under EU MDR and FDA

Post-Market Surveillance under EU MDR and FDA: From Compliance to Strategic Advantage

CE, EU MDR, FDA, IVDR, QMS, QMSR, Regulatory

Many manufacturers still treat Post-Market Surveillance (PMS) as a regulatory checkbox. That approach doesn’t hold anymore. Under the EU MDR, PMS is a structured and mandatory framework for all medical device classes. It requires continuous, proactive data collection and evaluation throughout the product lifecycle. On the FDA side, the terminology may differ, and a formal

Post-Market Surveillance under EU MDR and FDA: From Compliance to Strategic Advantage Read More »