PMA 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 »