By adhering to FDA recommendations and leveraging the expertise of proven cyber testing methods, manufacturers can tackle known cybersecurity issues today while also attempting to anticipate concerns that may lie ahead.
This year’s MEDICA will showcase on current trends and applications in wearable technology.
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
The new European Regulation related to medical devices – as adopted by the European Union (EU) Council on 5 April 2017 – does not provide 3D printing with a specific status, raising questions regarding the regulations applicable to this medical innovation.
Overall, MDSAP will reduce the time and resources required for audits and inspections, and aid in international trade.
As Asians get wealthier and more concerned about how they look, opportunities in Asia’s aesthetic market will skyrocket.
How software is changing the legal landscape for medical device manufacturers.
In the past, few people thought about medical devices falling victim to hackers. But as internet technology and changes in healthcare converge, medical devices are proving to be an easier target for hackers than we thought.
Tips to navigate what can be a grueling undertaking.
In the United States, nearly 4500 devices will be relabeled and 500 devices removed due to the risk of thrombus formation in the device.