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Ideas shaping health technology
News, guides and analysis on medical devices, regulatory affairs, quality and health technology.
Aleph Innovation Hub: from the classroom to the FDA, under one roof
October 13, 2026
Aleph University launches the Aleph Innovation Hub, a medical device innovation ecosystem with Sigma Scientific that joins graduate education, accredited testing and...
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Introducing Aleph School: continuing education for professionals who lead change
October 6, 2026
Aleph University launches Aleph School of Professional & Continuing Studies, a new school of online courses in leadership, agility, business, technology and...
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The Aleph Scholarship: our bet on the talent that will transform healthcare
September 29, 2026
Aleph University offers a need-based scholarship for master's students that covers up to 50% of each semester's tuition. Here is who it...
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Is this master’s degree right for me? 7 questions to ask before you apply
September 22, 2026
Before you apply to an online master's degree, answer these 7 questions honestly. They will tell you whether this is your moment,...
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AI in Medical Devices: The Regulatory Challenge Reshaping the Industry
September 18, 2026
How do you approve a device that keeps learning after launch? What the FDA and the EU have answered so far, and...
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Regulatory Affairs vs. Quality Assurance: Differences Every MedTech Professional Should Know
September 18, 2026
RA and QA get confused constantly in medical devices. What each function actually does, why they complement rather than compete, and which...
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Medical device careers in the U.S.: what the job market shows in 2026
September 15, 2026
What the data says about jobs, salaries and growth in the U.S. medical device sector, and why regulatory affairs and quality roles...
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Aleph University and Biomedicampus Join Forces to Strengthen Clinical Engineering Training
September 8, 2026
Aleph University and Biomedicampus signed an academic and commercial agreement that brings thirteen specialized clinical engineering courses to the Aleph community, with...
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Online vs. On-Campus Master’s: The Real Question If You Already Work Full Time
August 21, 2026
If you already work full time, the question is not whether online “is worth the same,” but which format fits your life....
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AI in Healthcare: The New Wave of Jobs for Regulatory Experts
August 21, 2026
AI applied to regulatory affairs is growing near 23% a year and driving demand for hybrid profiles who understand both the rules...
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Regulatory Affairs Specialist Salary in the U.S. and Latin America
August 21, 2026
How much a Regulatory Affairs specialist earns in the U.S. and Latin America, what factors move the salary, and how to calculate...
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Who Leads the Medical Device Market in Latin America? The Complete 2026 Ranking
August 21, 2026
Latin America’s medical device market is heading toward USD 55 billion by 2035. Here is the 2026 map of who manufactures, who...
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ISO 13485 Explained: The Standard Every Medical Device Professional Should Know
July 25, 2026
What ISO 13485 is, what it requires, how certification works, and why mastering it — alongside the FDA QMSR, ISO 14971, and...
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How to Apply to an Online Master’s Degree in the U.S.: Aleph University Admission Requirements
July 21, 2026
A clear, eight-step guide to Aleph University’s 100% online master’s admissions: requirements, profiles we look for, scholarships, and how to apply. No...
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Class of 2026: Inside Aleph University’s Commencement Ceremony
July 13, 2026
Inside Aleph University’s Class of 2026 commencement in Weston: the procession, the speeches, the student voices, and the moment a new class...
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The Regulatory Affairs Specialist: The Role That Decides Whether a Medical Device Reaches the Market on Time
July 13, 2026
A Regulatory Affairs specialist turns science into approvable documentation — deciding whether a medical device reaches the market on time. What the...
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The Medical Device Development Process: From Concept to Market
June 18, 2026
The five stages of the medical device development process, from concept and prototyping through verification, regulatory approval, and post-market surveillance.
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Biomedical Signal Analysis: Reading the Body’s ECG, EEG, and EMG
June 18, 2026
An introduction to biomedical signal analysis: the ECG, EEG, and EMG signals the body produces, how engineers process them, and how machine...
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Medical Informatics, Telemedicine, and eHealth: A Practical Primer
June 18, 2026
How medical informatics, telemedicine, and eHealth work together: health information systems, the benefits of remote care, and the privacy and data challenges...
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Medical Device Testing: Safety, Performance, and the Standards Behind It
June 18, 2026
A guide to medical device testing: IEC 60601 safety, ISO 10993 biocompatibility, verification and validation, and why accredited labs and test evidence...
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How a Drug Gets Approved: IND, NDA, ANDA, and BLA Explained
June 18, 2026
A clear guide to the FDA drug approval process: the IND, the three clinical trial phases, and how the NDA, ANDA, and...
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Medical Imaging Systems Explained: X-ray, CT, MRI, and Ultrasound
June 18, 2026
How the main medical imaging systems work and differ: X-ray, CT, MRI, and ultrasound, their clinical uses, trade-offs, and why they are...
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Medical Device Labeling: UDI, IFU, and the Rules That Matter
June 18, 2026
A practical guide to medical device labeling: what counts as labeling, how the UDI system works, paper vs. electronic IFU, and key...
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ISO 13485 and the FDA QMSR: Quality Management for Medical Devices
June 18, 2026
What the ISO 13485 quality management system requires, how it differs from ISO 9001, and why the FDA QMSR made it central...
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