Medical and Combination Device Questions

What is combination product testing? Combination products deliver biologics and other pharmaceutical agents accurately and dependably to the point of need. Validation and batch testing for these systems examine... More

What medical device testing methods do I need to comply with? A test method should follow good logic, planning and start with a risk analysis. Once the failure modes... More

What is biocompatibility testing for medical devices? According to the MDR and FDA regulations biocompatibility must be demonstrated for all medical devices. If a device is biocompatible if performs... More

What is extractables and leachables testing? It is obviously undesirable for a medication or a medical device to introduce unwanted substances to the human body. E&L testing investigates substances... More

What testing is required to validate medical device packaging? Sterile barrier packaging for medical devices must be validated according to ISO 11607. The material specification is usually taken... More