As we rely on the proficiency of the medical device to perform as intended, the slightest deficiency in the medical device can provide tragic results.
Medical device testing evaluates various aspects of the medical devices to block the usage of the defective devices on patients. Medical device testing also demonstrates that the medical device is safe and reliable to use. In short Medical device, testing indicates Medical device is certified to perform as per intended use. Medical device testing facilitates you to provide evidence of its compliance with standards and regulations around the globe.
Medical device testing includes:
There are numerous labs available that provide testing for a wide range of the medical devices. The labs are selected based on the certifications it has. The testing protocol and report content used by the lab shall be approved by notifying bodies. The labs shall be ISO 17025 accredited. Various tests require the labs to be GLP certified.
We guide you on selecting the appropriate labs based on the requirements of your Medical device testing.
We interpret the test standards and guidelines to determine the test requirements and adequate test methods to be used for your device. We help you determine test parameters and acceptance criteria.
The general standard that is not specific to the medical device includes packaging ISO 11607, toxicity ISO 10993, IEC 62366.
It is a regulatory requirement ensuring that the device is compatible with the biological system where it will use.
Maven ProfservNovember 23rd, 2022
Hello Readers! A medical device manufacturer has to...Read More
Maven ProfservOctober 11th, 2022
Is your notified body asking you for a...Read More