IEC 62304 Archives - Methodsense, Inc

February 21, 2017
By Rita King
IEC 62304, Life Science Software, Risk Management

Cybersecurity’s Impact on Health Systems

We are currently seeing significant technological advances in medical devices, hospital networks and patient care. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect a device’s performance, functionality and safety to the patient....

IEC 62304 Software Development Life Cycle

Avoid Common Medical Device Software Development Life Cycle Pitfalls

Learn Potential Software Development Life Cycle Pitfalls to Pay Attention To IEC 62304 is the international standard that defines software development life cycle requirements for medical device software. IEC 62304 was developed from the perspective that product testing alone is insufficient to ensure patient safety. It provides a common framework for medical device manufacturers to develop...

February 17, 2015
By Rita King
IEC 62304, Medical Devices, Risk Management

Is Your Medical Device a Secret Safety Risk?

WHEN: Thursday February 26th WHERE: Your office TIME: 1.30pm – 3.00pm REGISTER HERE Compliance with IEC 62304 is required for all electromedical devices where basic safety is dependent on software or firmware. But many device companies remain unaware that the devices they manufacture must meet this standard. That may be because there’s confusion stemming from a key...

September 15, 2014
By Rita King
FDA Compliance, IEC 62304

Understand how the FDA uses the IEC 62304

IEC 62304 Safety Requirements FDA medical device recalls are on the rise. An increasingly active FDA, coupled with the rise in software components for medical devices is adding up to new challenges for manufacturers. Given this reality, it’s important to understand how the FDA uses the IEC 62304, an international standard developed that, among other things,...

July 29, 2014
By Rita King
FDA 21 CFR Part 11, FDA Compliance, IEC 62304, Quality Management

Medical Device Data Systems and Data Integrity

Time to Take a Closer Look at FDA MDDS Moves The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and display medical device data. An MDDS does not modify the data, and it does not...

Category: IEC 62304

Cybersecurity’s Impact on Health Systems

Avoid Common Medical Device Software Development Life Cycle Pitfalls

Is Your Medical Device a Secret Safety Risk?

Understand how the FDA uses the IEC 62304

Medical Device Data Systems and Data Integrity