Medical Device – Medical Alley Association

Medical Device

Critical Factors in Designing, Developing and Securing Medical Device Software

As devices get more connected and more capable, developing them becomes more complex. In this blog we share an overview of four key areas — UX/UI design, software development, regulatory compliance, and medical-software cybersecurity — and offer effective processes and best practices to follow as you work toward medical device certification. Thoughtful Design, Meticulous Development […]

Spark Biomedical and Velentium Named ‘Most Innovative’ in Houston

MedTech companies honored at the Houston Business Journal’s third-annual Innovation Awards for life-changing neurostimulation device HOUSTON, TX – October 13, 2021 – Spark Biomedical (Spark) – a Texas-based medical device company and developer of the first drug-free, personalized, wearable solution for opioid withdrawal relief – and Velentium – a professional engineering firm that specializes in the design and manufacturing […]

Boulder iQ Sterilization Business Receives $250,000 Grant, Helps Medical Devices Get to Market Faster

BOULDER, COLO. (PRWEB) JUNE 09, 2021 Boulder Sterilization Services is the recipient of a $250,000 grant from the Colorado Office of Economic Development and International Trade’s Advanced Industries Accelerator Grant Program. Boulder Sterilization Services offers quick-turn contract sterilization for medical devices. The type of sterilization it offers, ethylene oxide, is a safe, low-temperature, environmentally friendly process that is […]

Francis Medical Announces Positive Data from VAPOR 1 IDE Study for Water Vapor Ablation of Prostate Cancer

MINNEAPOLIS (June 8, 2021) – Francis Medical, Inc., a privately-held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney, and bladder cancer, today announced positive results from the company’s VAPOR 1 clinical study evaluating the safety and efficacy of the company’s minimally invasive water vapor ablation […]

MDR Article 117: Implications for Drug-device Combination Products

Manufacturers of combination products should seek regulatory advice and operational support from the expert Celegence team to ensure that essential documentation and clinical evidence for your product portfolio complies under the new MDR. To discuss how our team can strategically partner with yours, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device […]

Researchers Unveil a New Theory Explaining Long-Term Pain Relief

Stimulation of peripheral nerves warrants consideration early in the care continuum. Cleveland, Ohio- March 15, 2021- A novel theory recently published in the Journal of Pain Research proposes mechanisms by which a 60-day treatment using percutaneous peripheral nerve stimulation (PNS) may recondition the central nervous system (CNS) to restore normal pain processing and provide long-term pain relief for […]

For the Record with Chad Robran and Peter Cole, Bone Foam

Chad Robran is the President & CEO for Bone Foam, Inc. a globally recognized medical device leader serving patient positioning needs in hospitals, clinics, and surgery centers throughout the world. Bone Foam’s mission is to be the unequivocal best in patient positioning by innovating products that save time, save money, and serve patient/provider safety. Chad […]

Boulder iQ Selects CardioScout for Medical Device Accelerator Program

BOULDER, COLO. — MARCH 09, 2021 Boulder iQ’s Boulder Medical Device Accelerator (BMDA) has selected CardioScout Innovations, Inc. as its first 2021 member. Founded in 2019, BMDA provides equity investment in start-up companies seeking product development services, expert mentoring and infrastructure support. Each year, BMDA will accept up to five start-up companies in the healthcare/medical device field to […]

Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs): What the Changes Could Mean for Your Products

This is the seventh in a series of blogs related to some of the key challenges being encountered to the recent updates to EU MDR. The New EU MDR Guidelines The new EU MDR guidelines will involve a lengthy EU MDR checklist including an array of topics, ranging from general administrative information to verification and validation, amongst […]

Boulder iQ Introduces MDR Transition Program as One-Stop Resource for Upcoming Deadline

Medical device companies that still need to meet the looming Medical Devices Regulation (MDR) deadline for the products they sell in Europe now have a one-stop resource to ensure they are ready and in compliance. “The MDR Transition Program from Boulder iQ will take companies through every step required for MDR compliance, in advance of the May […]

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