医疗器械

医疗器械开发、检测与法规。

2026年8月25日

Biocompatibility Testing — ISO 10993 Series Overview

How the ISO 10993 series determines which biocompatibility tests a device needs based on contact type.

2026年8月25日

EU MDR (Medical Device Regulation) — Key Changes from MDD

The most significant changes the EU MDR introduced compared to the previous MDD framework.

2026年8月25日

ISO 13485 — QMS Implementation for Medical Device Manufacturers

What implementing ISO 13485 looks like in practice for a medical device manufacturer.

2026年8月25日

Medical Device 510(k) Submission — Key Requirements Overview

What a 510(k) premarket notification needs to demonstrate and commonly cited deficiencies.

2026年8月25日

Medical Device Classification — FDA Class I/II/III Overview

How FDA classifies medical devices into Class I, II, and III, and what that means for regulatory pathway.

2026年8月25日

Medical Device Design Controls: FDA QMSR and ISO 13485 Clause 7.3

What FDA's QMSR and ISO 13485 Clause 7.3 design controls require across the device development process.

2026年8月25日

Medical Device Risk Management — ISO 14971 Application

How ISO 14971 structures risk management across the medical device lifecycle.

2026年8月25日

Post-Market Surveillance — Requirements for Medical Device Manufacturers

What ongoing post-market surveillance obligations apply to medical device manufacturers.

2026年8月25日

Software as a Medical Device (SaMD) — Regulatory Classification Overview

How SaMD is classified by risk and what that means for the applicable regulatory pathway.

2026年8月25日

Sterilization Validation for Medical Devices — EO, Gamma, and Steam Methods

How the three common sterilization methods for medical devices are validated and compared.