Technology is ever-evolving, ever-advancing, and ever-changing. With all its positives, technology has also created challenges. They are even more pronounced in the healthcare industry where a person’s health, safety, and private information are involved. As continuous as the advancements are, equally as persistent are the malicious attempts to compromise these systems and take advantage of any weakness. As technology accelerates, so do cyber-attacks, endangering the safety and privacy of everyone involved in producing and using the device.
All software has potential cybersecurity vulnerabilities, and as you are looking for the most cutting-edge way to help your customers and patients, hackers are looking for creative ways to breach your software.
It is essential for medical device companies to be aware of this throughout their product lifecycle – in every aspect from design to development and manufacturing – so they can be intentional and thoughtful to mitigate the risks. As the world becomes more connected and digital, security risks are becoming more prevalent and numerous, and medical device companies must be more diligent.
This whitepaper offers an insightful overview of the current state of medical device cybersecurity, commonly overlooked cybersecurity threats, and ways to mitigate them.
The terms Application Lifecycle Management (ALM) and Product Lifecycle Management (PLM) are frequently used interchangeably. And while the two are often intertwined, they are not the same thing....
Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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