Clinical Evaluation Of Reusable, Measuring and Sterile Class I Medical Devices
Class I medical devices under the EU MDR are considered low-risk devices. These medical devices are usually non-invasive and for transient use, such as hospital beds or bandages, or [...]
510k When to Submit: Comprehensive Guide
If you are a medical device manufacturer considering entering the U.S. market, and you want to market your product, you must understand how and when to file [...]
ISO 13485 Certification in Saudi Arabia
At present, the healthcare industry in Saudi Arabia is quickly developing. While the global demand for reliable medical supplies grows significantly, it is critical to establish the [...]
ISO 13485:2016 Consultants
Our ISO 13485 consultants have hands-on expertise setting up quality management system for medical devices designers, [...]
MEDICAL DEVICE CLINICAL EVALUATION : AN OVERVIEW
M edical Device Clinical Evaluation is a procedure to collect, assess, analyze a clinical data based [...]
Biological Safety of Medical Devices
B iological safety of the medical device is an important requirement for market approval. It is [...]
Single Registration Number (SRN for Medical Devices)
SRN for Medical Devices: The Single Registration Number (SRN Number) identifies every economic operator in and [...]
Clinical Evaluation Literature Search
The basis of your device CERs is Literature Search. If you're in charge of compliance for [...]
Medical Device Labelling
Medical Device Labelling: A label is the written, printed, or visual information that appears on the [...]