Community

Acceptance sampling is a technique often used in verification of product. The sampling methods depend on either variables or attributes. Most device companies used published documents such as Z1.4, c=0, or Z1.9. There are other methods, although not ...

Hello All: In ISO 14971 Medical Devices--Application of Risk Management to Medical Devices clause 4.3 is "Identification of Hazards." It requires the manufacturer to compile documentation of known and foreseeable hazards associated with the medical d...

Hi,I was hoping to get some help and alternative opinions on a classification query I have. We sell instrument trays used to hold the instruments during reprocessing and sterilisation. I'm not sure whether they should be classified as a medical devic...

Someone told me that it's possible for a med device company to use their contract manufacturer's ENTIRE quality system as their own. He said since design and development is outsourced, his company could just use all of the manufacturer's procedures a...

To get an CE Mark for a device which needs to go to a clinical study and do not have any results to proof the safety and performance requirements. Is there a similar process/procedure in Europe like in Us for the IDE (Investigational Device Exemption...

What (exactly) does it take to orchestrate and command a successful launch of an entirely new medical device? Such as a device that can be categorized as the "next revolution" in a medical specialty and/or represents a disruptive technology. I am par...