Question
I would like to check what is in your experience the best way to make sure that security patches installed by a hospital on your device are validated prior to installment? or in other words, what is the best way to ensure hospitals contact you when i...
Hopefully nothing. It faces stiff opposition in the Senate. But I chose the American Health Care Act (AHCA) as this week's topic because nearly every major constituency affected by the bill opposes it. A concise writeup at http://medcitynews.com/2017...
I want to ensure we maintain conformance to 820.80 and also incorporate the risk-based approach to acceptance activities. We are looking for potential opportunities to reduce or eliminate inspections based on the item such as supplies vs raw material...
Hippocrates said "Let food be thy medicine and medicine be thy food." E-Motion Medical goes further: Thy food is thy medicine only if you can swallow it and keep it down. To ensure patients get the nutrition they need to heal, E-Motion Medical set ou...
Three different clients of mine have recently received 510(k) deficiency letters from the FDA related to human factors. I have heard similar feedback from colleagues that specialize in FDA submissions. The FDA guidance document has not changed since ...
Hello, i'm working in spinal implant manufacturing company. DHF formalises input, output, verification, validation, review and transfer. After post production we continue to create revised DHF for design changes. Our DHF is system based e.g. Cervical...
Some companies ask physicians that helped them with product development review draft IFUs. However, these physicians are already familiar with your product, your company and they are highly skilled in the specific procedures your device will be used ...
I read a valuable paper from ICON plc about hitting cost efficiencies while still achieving productivity and growth. You can download it for free at http://medgroup.biz/ICONplc Entitled "Achieving Challenging Mandates for Cost Savings and Pipeline Pr...
It has now been some time since the release of the updates ISO 9001 and ISO 13485. There was some discussion in this group about how many medical device manufacturers maintain both ISO 9001:2008 and ISO 13485:2003 certification.It would be really goo...
If you receive an NSE letter from the FDA, you have four options for correcting the problems and resubmitting your device to the FDA. However, you want to avoid receiving a second NSE letter for the same FDA.There are four causes for receiving an NSE...
