Marketing materials from BesTech
BesTech publishes a simple information sheet/brochure that is available in Adobe Acrobat (pdf) format. To download the file, click here.
A presentation in pdf format is available for download also. This presentation supplies some additional background information about BesTech. Click here to download the file.
Note that you will need Acrobat Reader (version 7 or higher) to read the files on this page.
Risk management
Below you will find a few files about risk management. Some of these articles are older, but still valid and valuable.
Risk management flow 2007.pdf: a flow diagram taken from the Risk Management standard ISO 14971:2007. Download here.
Design control flow.pdf: a flow diagram showing how to integrate risk management with design control. Download here.
Develop defensively.pdf: philosophy and tips for integrating risk management with design control. Download here.
Establishing risk.pdf: an article about the need for medical device makers to establish the residual risk of their device. Download here.
Software in medical devices
Software plays an increasingly important role in medical devices, and in the past decades the FDA has taken many initiatives to regulate the safety and effectiveness of software.
Software Risk Management for Medical Devices.pdf: an article about applying risk management principles to software development. Download here.
FDA guidance sw validation.pdf: "the" software validation document. Download here.
FDA guidance software.pdf: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The title says it all. Download here.