Medical Device Software Regulations

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....

How the 21st Century Cures Act Impacts Medical Device Software

There has been a lot of discussion surrounding medical device software and how it should be regulated. Concern about software of this nature will continue to rise to the forefront of conversations because there will be an increasing number of these products in the marketplace. The 21st Century Cures Act specifically addresses which types of...

December 14, 2016
By Rita King
FDA Compliance, Medical Devices

Obama Signs the 21st Century Cures Act into Law

21st Century Cures Act into law. Most of what people will be hearing from the media will be focused on the Act’s support of cancer research, mental health policies, brain research to tackle diseases like Alzheimer’s and the funding allocated for these initiatives. However, the 996-page bill also includes major changes that impact the way...

September 7, 2015
By Rita King
FDA Compliance, Medical Devices

Software and the FDA Refuse to Accept Policy for 510(k)s 2015 Guidance

The path to medical device commercialization requires FDA clearance, which most often means filing a pre-marketing notification, also known as a 510(k). The FDA has specific criteria for accepting a 510(k), and they just released their new acceptance policy. This new standard, which will be effective October 1, 2015, replaces the old FDA Refuse to...

Colliding Cultures: Software Development and the Medical Device Industry

Part 1 – Medical Device Software, the FDA and the US Congress Preface: In any given 2-week period, an average of 15% to 20% of the applications on my smartphone have new versions to fix software bugs. Others I speak with experience similar statistics. And, that doesn’t include how often my smartphone software crashes while...

FDA Issues Final Guidance on Reusable Medical Devices

Endoscopes Linked to “Superbugs” Lead to New FDA Guidance for Reusable Medical Devices UPDATE The FDA has released the slides from their presentation on Reprocessing Medical Devices. Get the slides here. In light of the fatal “superbugs” that have been plaguing hospitals after using endoscopes, the FDA has released new guidance for reusable medical devices....

March 5, 2015
By Rita King
FDA 21 CFR Part 820, Quality Management, Risk Management

Implement 21 CFR Part 820 Controls Early On

Benefits and Risks of Moving to the Cloud Migrating to the Cloud: What are the Benefits? According to the National Institute of Standards and Technology, the cloud is “a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly...

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...

Tag: Medical Device Software Regulations