08Feb
Decoding FDA’s Draft Guidance On CSA
The current state of validation is seen as a hindrance to quicker deployments, with an emphasis on adhering to thorough documentation practices instead of building systems that align effectively with their intended use. A risk-based approach to validation has been around ...
Read more08Nov
FDA gives full recognition to AAMI cybersecurity guidance document
FDA grants full recognition to AAMI's pioneering guidance document on medical device cybersecurity, ANSI/AAMI SW96:2023, Standard for medical device security - Security risk management for device manufacturers.
Read more04Oct
FDA Issues Final Guidance on Cybersecurity in Medical Devices
he U.S. Food and Drug Administration (FDA) has recently unveiled its comprehensive final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
Read more01Jul
FDA Premarket Notification 510(k)
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). There is no 510(k) form; however, 21 CFR 807 Subpart E
Read more20Jun
Clinical Decision Support Software Regulations
We will mainly comment and ask critical questions on the practical implementation of the regulatory framework for medical device software (especially clinical decision support software), with a reference to the available international guidance documents and their limitations. As ...
Read more22May
3 Key Benefits Of Deploying Edge AI At The Point Of Care
The point of care is shifting, with monitoring, diagnosis, and treatment taking place increasingly outside the conventional hospital setting and moving into patients’ homes. This is an exciting shift in the paradigm of healthcare. The arrival of cloud computing has allowed ...
Read more05May
New EU Directive Marks Cybersecurity Regulatory Paradigm Shift
The increasing degree of digitalization and interconnectedness, along with the rising number of cyber malicious activities at the global level, has effectively rendered cybersecurity an increasingly valued position on a business level.
Read more25Apr
Mobile Health Apps – which U.S. federal laws may apply?
The Federal Trade Commission (FTC) has published on its web site an interactive tool that helps mobile health apps manufacturer to navigate laws and rules that may apply to their app. Privacy and security are important considerations for any app ...
Read more20Apr
The Evolving FDA Regulatory Landscape of Artificial Intelligence
Whether it’s asking ChatGPT to rewrite your resume, getting behind the wheel of a self-driving vehicle, trusting the cybersecurity protocols of the cloud-storage platform to which you’re saving your family vacation photos, or ...
Read more06Apr
The Road To ISO 13485 Certification: Tips For Effective Audits
We all know a moving target is hardest to hit. Whether it’s a high-speed tennis ball or an audit, keeping your eye on the target at all times is the key to success. Even the mention of the term “audit” can send people cowering ...
Read more14Mar
The Buzz About Medical Device Cybersecurity in 2022 and Beyond
Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance ...
Read more17Feb
Top ten observations from 2022 in life sciences digital and analytics
Life sciences companies are making progress in adopting and deploying digital and analytics. But they can go further and faster by heeding some lessons from the past few years. Looking toward the new year is a good time ...
Read more05Feb
The health benefits and business potential of digital therapeutics
Around the world, the burden of chronic disease is increasing at a rapid pace. Unfortunately, most of these conditions are irreversible and need to be managed through lifelong medication use. However, many patients ...
Read more15Jan
The FDA & EU IVDR Regulatory Frameworks For IVD SaMD
Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746. Therefore, ...
Read more05Jan
GPT Applications in Healthcare?
Natural language computer applications are becoming increasingly sophisticated and, with the recent release of Generative Pre-trained Transformer 3, they could be deployed in healthcare-related contexts that have historically comprised ...
Read more19Dec
IVD Software as a Medical Device (SaMD)
In recent years, software has been playing an increasingly critical role in the medical device world. Software with a medical intended use can be embedded as part of a medical device (and regulated as part of the device) or it can also be considered a medical device by itself ...
Read more08Dec
Time extension for MDR transition
The EU Commission will present elements of a legislative proposal for a targeted amendment of the MDR and IVDR during the EPSCO Health Council on 9 December 2022. Those elements are based on the input received so far from national experts and stakeholders ...
Read more30Nov
The promise of digital therapeutics
Investments in digital-therapeutics companies in the United States have grown by an average of 40 percent a year over the past seven years to reach more than $1 billion in 2018. Investors’ enthusiasm mirrors the growing demand for digital-therapeutic products ...
Read more28Nov
What’s Wrong With Your Medtech R&D Department?
Larry Blankenship, director of Boulder iQ wrote in the current issue of www.meddeviceonline.com: “Voicing complaints about R&D departments in medical device companies is nothing new. Executives, staff members, and investors commonly ask, “What’s wrong with ...
Read more23Nov
Five ways that life science companies can build tech talent
Life science organizations should have little difficulty attracting and retaining tech talent. The salaries that they offer are typically higher than those in other industries. The work—improving health and the quality of life ...
Read more19Nov
FDA vs. Congress: The Software Showdown
September 2022 will be remembered as a seminal turning point in digital health in the U.S. It was not FDA’s concluding its Software Precertification Pilot program, where the FDA finally admitted and further validated our cGMPs for SaMD approach1 that a new legislative authority ...
Read more14Nov
Are you Submission Ready?
Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time and effort that truly goes into being “submission-ready.” It is important not to underestimate the large amount ...
Read more10Nov
FDA’s New Draft Guidance on Cybersecurity
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device lifecycle. There are several major changes ...
Read more26Oct
Tips For Your Virtual Meetings With The FDA
In the past two years, the pandemic has kept sponsors developing drugs, biological products, and medical devices from meeting in person with FDA. Advisory committee meetings, workshops, and conferences have gone virtual, too. While some sponsors have hopes ...
Read more21Oct
Medtech Cyber-Incidents – A Costlier Problem Than You Think
To help medtech companies understand their business-threatening cyber risks, we offer an infographic and related taxonomy classifying cyber risks into five categories of harmful events — operational interference, ...
Read more17Sep
The 5 Common Medical Device Startup Challenges (& How To Overcome Them)
The medical device market is diverse, fast-moving, and powered by dynamic customer needs and ongoing demand. Anticipated to reach $734.39 billion by 2027, the market is a land of both opportunity and risk for enthusiastic, ...
Read more23Jun
FDA Releases Guidance On Cybersecurity In Medical Devices
The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare environment, both in the hospital ...
Read more09Jun
Key Design Considerations For Digitally Connected Injectors
Digital health has become an integral part of clinical trials and the commercial patient support ecosystem. In the past two years, there has been a significant transformation in the way clinical trials are conducted, as well as how healthcare providers support patients ...
Read more30Apr
Medical Device Interoperability
Medical device interoperability is the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. This exchanged information can be used in a variety of ways including display, ...
Read more31Mar
How To Update my QMS for FDA QMSR Amendment Compliance?
Now that the FDA has officially announced its intention to harmonize and modernize 21 CFR Part 820 Quality Management System Regulation (QMSR) for medical devices, the question is: What do I need to do to my quality management system (QMS)? If your QMS is based on ...
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