Technical Operations leader at Insulet Corporation
Thank you for your time and congratulations on your involvement in Medical Devices. I am writing because I am considering a shift in career toward medical device manufacturing. My background is management of high-tech/computer manufacturing and test ...
Quality Assurance Manager at Entellus Medical, now a part of Stryker
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...
VP Quality and Regulatory at MicroGroup
Most likely something discussed in the past and hopefully answered easily. We have been completing our 21 CFR Part 820 compliance and are in really good shape for a contract manufacturer of medical devices. I have been receiving competing information...
Product at Striiv, Inc.
Hi Everyone, We're new to the FDA medical device, and we're looking to implement an eQMS system into our workflow. We've looked at Greenlight Guru, MasterControl, and Enzyme. Was hoping to get some feedback from the folks here regarding the pros/cons...
RA Officer at LiNA Medical
If a GMDN database is the same as TGA GMDN database? Or maybe they are two different bases??I found the website GMDN agency, but I can't find TGA GMDN website...If Australia has its own GMDN code?
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Even before the FDA’s final rule was published for UDI in 2013, companies were implementing UDI systems. What has not been clear is how the FDA would enforce UDI compliance. The most logical methods of enforcing UDI compliance are:1. require a draft ...
Michael Chellson, RAC
Principal at Pathways to success consulting
CAPA-Corrective and preventive Action...Every day a seminar on CAPA is being held somewhere, it’s one of the simplest, but most misunderstood process we deal with every day!Many companies have not only their "formal" CAPA process, but also have sever...
Chief Operating Officer at Medpoint, LLC
Does anyone have first hand experience or recommendations for a 3rd party outsourced provider for turnkey management of medical device complaint handling and postmarket surveillance services?source: https://www.linkedin.com/groups/2070960/2070960-630...
CEO at Medicen Devise Limited
Hello, I am going for a CE Mark for my class IIa device. In order to understand the process better I came across STED scheme. I was wondering if someone has taken their device through STED and what was their experience?source: https://www.linkedin.co...
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During the next three years I guarantee that every single medical device manufacturer will eventually become sick and tired of hearing the phrase “risk-based approach.” I’ve been there for about 5 years, but there are a few new updates to the standar...