Vantage Medtech offers comprehensive regulatory and clinical consulting for medical devices, ensuring compliance and successful market navigation with over 30 years of expertise.| Vantage Medtech
Vantage Medtech offers specialized cybersecurity for medical devices, ensuring compliance with FDA and EU standards to protect patient data and device integrity.| Vantage Medtech
As of September 2023, all medical device manufacturers (MDMs) must demonstrate their device’s adherence to FDA cybersecurity standards in their premarket submission. Following medical device cybersecurity standards can be the difference between approval or not. The FDA has released guidance documents that outline how medical device manufacturers should handle cybersecurity. These guidelines are not legally| Vantage Medtech
Medical devices are a staple of modern medicine and are responsible for many of the innovations in healthcare we see today. However, they aren't all made equal and do carry their own degree of risk and harm. That's why governing bodies introduced medical device classes I, II, and III (sometimes medical devices classes 1, 2,| Vantage Medtech -
Bring complex medical devices to market with confidence. From strategy and design to manufacturing, our expertise transforms ideas into market-ready solutions.| Vantage Medtech - Together We'll Save Lives
LENEXA, KS and MOONACHIE, NJ, April 30, 2025 — Vantage MedTech, a leading provider of comprehensive design and manufacturing services for medical technology innovations, today announced that Mike Taylor has joined the company as Chief Financial Officer. Mike brings over 25 years of experience as a senior finance and business leader, with extensive background in […] The post Vantage MedTech Appoints Mike Taylor as CFO first appeared on Vantage Medtech.| Vantage Medtech
In 2024, 107 AI-enabled medical devices received FDA approval, bringing the total number of FDA approved devices to over 950. There’s no question that AI technology is becoming common in medical device development projects, but how are medical device design standards evolving to keep pace? On January 6, 2025, the FDA released […] The post Medical Device Design Standards for AI-Enabled Devices: A Total Product Lifecycle Approach first appeared on Vantage Medtech.| Vantage Medtech
Cryoablation and radiofrequency (RFA) are two common ablation modalities for treating atrial fibrillation (AF), problematic tissue treatment, and other conditions. RFA is the long-standing method for ablation therapy, however, cryoablation use is increasing, especially for AF treatments, sparking discussions and studies around cryoablation vs radiofrequency ablation. While both are minimally invasive and effective, they […] The post Cryoablation vs Radiofrequency Ablation an...| Vantage Medtech
LENEXA, Kan. and MOONACHIE, N.J., November 19, 2024 –Vantage MedTech, a leading provider of comprehensive design and manufacturing services for medical technology, today announced that Kimberly Subrahmanyan has joined the company’s leadership team as Sr. Vice President of Technical Services and Program Management. Kimberly is an accomplished technology leader with extensive experience driving complex programs […] The post Vantage MedTech Appoints Kimberly Subrahmanyan as PMO and Enginee...| Vantage Medtech
MOONACHE, N.J. and LENEXA, Kan., November 13, 2024 – Sterling PLM, a Vantage MedTech Company has announced it is rebranding as Vantage ALM. Vantage ALM helps engineering companies across the globe implement proven processes that govern successful product development, spanning Life Sciences, Automotive, Aerospace, Heavy Machinery, and Industrial Automation. Their focus is on browser-based requirement […] The post Sterling PLM announces new branding as Vantage ALM first appeared on Vantage ...| Vantage Medtech
Radiofrequency, a common energy used in ablation therapies, is used for treating damaged, diseased, or malfunctioning tissue with minimally invasive procedures. However, recent developments are leading to frequent comparisons of pulsed field ablation vs radiofrequency ablation; pulsed field ablation has become an attractive option in some cases over radiofrequency ablation. While radiofrequency ablation […] The post Pulsed Field Ablation vs Radiofrequency Ablation: A Compari...| Vantage Medtech
Medical devices are integral to healthcare. Product development must be reliable, safe and effective, but also drive revenue. Therefore, when creating a new device for use in the USA, the FDA-regulated, 5-step medical device product development process must be followed. Knowing how to navigate these steps during the product development project is key […] The post From Concept to Market: Understanding FDA Medical Device Product Development first appeared on Vantage M...| Vantage Medtech
Bringing a medical device to market is an impressive feat. Strict regulations, fierce competition, and high development costs add complexities to the development journey unseen in other industries. Having a strong development and launch strategy by your side is crucial; a well-defined medical device go-to-market strategy is key to ensure a successful product […] The post The Medical Device Go-To-Market Strategy: The Foundation for Medical Device Success first appeared on Vantage M...| Vantage Medtech
New Brand Reflects Vast Experience and Commitment to Continued Innovation in the Medical Technology Industry Moonachie, NJ and Lenexa, KS, September 12, 2023 – Sterling Medical Devices and RBC Medical Innovations announced today the rebranding of the combined company as Vantage MedTech. Leveraging decades of industry experience and the specialized expertise of more than 150 medical […] The post Sterling Medical Devices and RBC Medical Innovations Rebrand as Vantage MedTech first appeared...| Vantage Medtech
MOONACHIE, N.J. and LENEXA, Kan., Feb. 14, 2024 /PRNewswire/ — Vantage MedTech announces the launch of its new website, VantageMedTech.com highlighting its comprehensive life cycle solutions enabling medical device innovations. The enhanced website experience is the culmination of the previously announced merger of Sterling Medical Devices and RBC Medical Innovations and subsequent rebrand to Vantage MedTech. Vantage MedTech leverages its team of 150+ medical device […] The post...| Vantage Medtech
While there are several countries working to develop their medical technology, the current answer to the question “what country leads the world in medical innovation?” is the United States.| Vantage Medtech
A patient monitoring system is a set of systems that enable medical professionals to monitor a patient’s health, and this technology is improving the way health care is delivered in the United States by reducing costs and improving outcomes for patients.| Vantage Medtech
Learn how Vantage MedTech designs cutting-edge software systems for medical devices. Discover our approach to building robust and compliant solutions.| Vantage Medtech
Regulatory affairs for medical device software design are complex. However, understanding the regulations behind development is crucial to getting your device to market.| Vantage Medtech
With the updated FDA software guidance for medical devices, manufacturers and developers have a better understanding of premarket submission requirements and guidelines.| Vantage Medtech
The FDA released its medical device cybersecurity guidance for premarket submissions. The guidance is applicable to any device or software that can connect to the internet.| Vantage Medtech
Now, more than ever, healthcare is leveraging software technology to further patient care. The healthcare industry’s rising dependence on technology is| Vantage Medtech
Biocompatibility testing for medical devices is a critical process that ensures devices are safe for their intended use in humans. As the name implies,| Vantage Medtech
The global reliance on electronic components is ever increasing, and consumers today are accustomed to seeing electronic devices become obsolete in less| Vantage Medtech
It’s hard to recall a time when software wasn’t standard in electronic medical devices. Creating safe, issue-free software is a critical aspect when| Vantage Medtech
Medical device development and cybersecurity are crucially linked. Internet of Things (IoT)-enabled devices for diagnostics and patient care are on the| Vantage Medtech
Medical device software is a rapidly evolving field. The United States currently leads in this sector, producing 45% of medical device software tools,| Vantage Medtech
Mobile healthcare apps are in high-demand. One 2022 study found that 46.7% of smartphone users have a mobile health app installed on their phone. While| Vantage Medtech
