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.
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.
If a device establishment is going to invest significant time and money into building a cleanroom or a controlled environment room, it makes zero sense not to perform proper monitoring of the environment.
Overall, MDSAP will reduce the time and resources required for audits and inspections, and aid in international trade.
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.
The corrective action is intended to reduce the risk of patient harm as a result of cybersecurity vulnerabilities in the products.
A guide to the steps companies can take to evaluate their device developer’s HFE process.
If an activity is not documented, it did not happen.
The Inspiris Resilia valve is intended for aortic valve replacement.
When responding to a 483 observation, clarity is a must: Both in communication and documentation.