Question
There are a few such products on the UK market that (from the CE mark and Notified Body number) are Class II devices. They are for sensitive teeth and I can almost understand how they could be pharmaceutical products since they have an active and spe...
As originally asked by Andrew Wallis. What is the average markup that a distributor adds on to the cost price for medical consumables? George Morphitis Director Dear Tzahi Alhough I agree with you that the Distributor knows better than anyone else th...
I'm trying to understand which countries' regulatory bodies have country of origin requirements and what does "country of origin" actually mean for these countries. Which countries have "country of origin" approval requirement for medical devices?If ...
Often I see companies performing design verification by manufacturing components, subassemblies, etc. and performing inspections and tests. In these instances, it appears to me that some device manufacturers have conflated design verification with ma...
Hello everyone,First, thank you for accepting me in your group.Can sterile medical devices be re-sterilized and used as new and according to standards/lows if they expired (as a product) but haven't been used? Re-packaging is also required?Thank you....
An independent reviewer is required for Design Reviewes. The problem in small start-up companies is that everyone is involved in the process and no one is really independent, on the other hand an external consultant may be very expensive for those co...
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 ...
Why I ask this? As a physician sometimes I have a feeling that in this group I'm not at home because it's mainly a group of businessmen, salesmen, distributors, engineers and others outside health practice with quite another way of thinking. Many of ...
Thoughts - A device such as ultrasound device, whose life span is 5 years. In its 6th year device does not work properly. The customer calls the manufacturer. The manufacturer offers to repair the device even though the device is outside its lifespan...
God bless Michael Seres. He was diagnosed with Crohn’s disease, an incurable bowel condition, at age 12. His first surgery at 14, he's 25 further surgeries stronger, having weathered intestinal failure and two bouts of cancer. He's now awaiting a ste...
