Question
Dr Fatima Zaid Abu Zanat
Regional Regulatory Affairs & Scientific Office Manager at Mundipharma International Limited
January 2016
Hi Colleagues!Does anyone have the medical device regulations/ guidelines for West Africa (Ivory Coast, Senegal, Mali, Cameroon, and Gabon)?How long does it approximately take to complete the registration process especially for Class IIb and III medi...
In a Warning Letter to Anybattery, Inc. FDA says that replacement batteries are accessories, manufacturers must register and list, and provide a 510(k) or PMA supplements as appropriate to the device that uses the battery.In the recent draft guidance...
Until I attended the 2016 World Patient Safety Summit, I had no idea 200,000+ lives are lost annually in the U.S. (3 million worldwide) to human errors. Below is President Clinton's keynote (an hour), and questions I asked Masimo CEO Joe Kiani (2 min...
Hi everyone, I need to define the class of a cleanroom required for the fabrication of a medical device. While looking at ISO14644 and ISO14698 I find any sort of information on how to design, validate and operate a cleanroom, I can't find any good g...
Companies developing devices with truly innovative technologies frequently have difficulty identifying suitable predicate devices. The best regulatory experts plan in advance for these regulatory submissions by honing their knowledge of the De Novo a...
During last week's JP Morgan Healthcare Conference, Andy Slavitt, acting administrator of the Centers for Medicare and Medicaid Services (CMS), said, "In 2016, meaningful use as it has existed – with MACRA – will now be effectively over and replaced ...
Healthcare conglomerate Johnson & Johnson said it will cut about 3,000 jobs within its medical devices division, or between 4 percent and 6 percent of the unit's global workforce, over the next two years.http://www.msn.com/en-us/money/companies/j...
source: https://www.linkedin.com/groups/2070960/2070960-6095219699472220163
Hello All,Say you're given a product that has passed design validation and is in mass production. The design engineers decide to widen the tolerance of a particular dimension, x.Does this change require design validation?Note: Said differently, the s...
Do you know what your Extended Producer Responsibility (EPR) reporting obligations are? I hadn't even heard of EPR until Graham Margetson, the CEO of Lorax Compliance, wrote me. When I saw he signed Fresenius Kabi as a client, I asked (and he agreed)...
