Question
A year ago, the panel of medical and academic experts at the US Policy Network’s annual meeting said that the fast-moving medical technology innovations are threatened by established interests and government regulations .The challenges of getting inn...
The real case is: A medical device is already long time on EU market and serving well to patients. Post market clinical follow-up have been performed and it delivered a lot of new clinical evidence which has been used in technical file of the medical...
Hello everyone,What's the content of your DoCs? According to the EU Official Journal published in 2008, the required content are: "1. No xxxxxx (unique identification of the product): 2.Name and address of the manufacturer and/or his authorised repre...
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...
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...
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...
CDRH published a list of guidance documents it is considering in fiscal year 2017. These include: Final Guidance Topics • Postmarket Management of Cybersecurity in Medical Devices • Medical Device Accessories: Describing Accessories and Classificatio...
