Question
The worst time to submit a pre-submission request is after you already started your verification and validation (V&V) testing. It’s too late because you are already committed to a testing plan. It takes 75-90 days for the FDA to schedule a pre-su...
3D medtech printing conference Maastricht presentation discussing 3D medtech printing under EU Medical Devices Directive and under future Medical Devices Regulation3D medtech printing under EU Medical Devices Directive and under future Medical Device...
After few years since the release of 2013/473/EU Commission Recommendation, I have the impression that the Unannounced audits are really becoming more and more frequent. Still, I haven't been able to find any publication discussing percentage of cove...
When writing a Hazard Analysis or FMEA, how much "pre-mitigated" control and design work can be assumed? The pre-mitigated risk level, which is used to drive design decisions, needs to be based on some "baseline" level of risk. But that "baseline" co...
I found an interesting paper from group member Tony Signorelli which illustrated the difference between medical device selling into physician practices and into hospitals and Integrated Delivery Networks (IDNs). When selling to physician practices, t...
The FDA has announced a plan to work with IBM and their AI program Watson to develop new ways to exchange health data across a variety of different platforms. Medical Device Daily has more:http://www.medicaldevicedaily.com/servlet/com.accumedia.web.D...
Hello everyone,With the changing face of education in many sectors to online education courses I wonder how many people or companies are changing or are thinking of changing to this form of education.In 2015 online education was a 105 billion dollar ...
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Most countries have some kind of database for gathering adverse event data for medical devices, but most of these databases are not open to the public. The most common question I am asked is, “How do you access the Eudamed database?” for reporting of...
Can someone share what and how he is doing packaging and labeling validation for a non sterile product ? Quantities? Parameters ? Forms ? How many batches ? source: https://www.linkedin.com/groups/2070960/2070960-6232416918385487874
