Blog

01Jul

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

20Jun

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 ...

22May

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 ...

05May

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.

25Apr

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 ...

20Apr

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 ...

06Apr

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 ...

14Mar

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 This follows FDA’s released Draft Guidance ...

17Feb

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 ...

05Feb

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 ...

15Jan

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, ...

05Jan

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 ...

19Dec

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 ...

08Dec

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 ...

30Nov

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 ...

28Nov

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 ...

23Nov

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 ...

19Nov

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 ...

14Nov

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 ...

10Nov

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 ...

26Oct

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 ...

21Oct

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, ...

17Sep

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, ...

23Jun

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 ...

09Jun

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 ...

30Apr

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, ...

31Mar

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 ...

18Mar

Increasingly, digital health technologies (DHT) are becoming part of the conduct of clinical trials for pharmaceuticals and medical devices. They cover an extremely broad range of applications, including ingestible ...

11Feb

Part 11 compliance has been around for about 20 years,1 but still today I see confusion in the industry. While most elements have been implemented successfully, in part attributable to the array of great software available in the marketplace, there are still areas ...

15Jan

While wearable medical devices1 offer the opportunity to monitor, diagnose, and deliver individualized care to patients, adoption by clinicians has yet to gain significant traction. However, the COVID-19 pandemic has raised awareness of wearables ...