ISO 13485:2016 Consultants
O ur ISO 13485 consultants have hands-on expertise setting up quality management system for medical devices designers, manufactures, exporters and traders, service establishments and testing laboratories. [...]
MEDICAL DEVICE CLINICAL EVALUATION : AN OVERVIEW
M edical Device Clinical Evaluation is a procedure to collect, assess, analyze a clinical data based on a clinical device to analyze whether there is sufficient [...]
Biological Safety of Medical Devices
B iological safety of the medical device is an important requirement for market approval. It is important for a medical device manufacturer to evaluate the potential [...]
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 [...]
What is 510k summary?
The 510(k) summary is an abstract of the details related to the proposed device included in [...]
User Manual Requirements for Medical Devices
A information supplied by the manufacturer to inform the user of a product's intended purpose and [...]
Single Registration Number (SRN)
What exactly is a Single Registration Number (SRN)? The Single Registration Number (SRN) is a unique [...]