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Featured

Photo by Mufid Majnun on Unsplash

Medical Device Compliance
Etienne Nichols
Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage. Fortunately, compliance with medical device regulations and standards is not an impossible task. A companywide emphasis on quality, along with the right tools for the job, can ensure that you stay…

Healthcare

Critical Aspects of Quality Management Systems

In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated quality management system (QMS) is key to maintaining this compliance. Let’s explore how QMS software streamlines validation and ensures regulatory…

Real-World Data and Real-World Evidence

While clinical trials are the gold standard for generating clinical data to use as evidence of your medical device’s safety and effectiveness, they are by no means the only way to gather clinical evidence.

Real-world data (RWD), which typically come from routine healthcare…

How Technology Supports ALCOA Principles

In the highly regulated world of life sciences, data integrity isn’t optional; it’s essential. The ALCOA principles—attributable, legible, contemporaneous, original, and accurate—provide a foundational framework for ensuring data are reliable and trustworthy.

With the rise of…

Four Ways to Measure Improvement Using Before/After Control Charts With Stages

Everyone has their own favorite graph type or visual tool. I’m not ready to declare this my favorite yet, but this oldie but goodie has got to get more time and attention. That’s right: I’m talking about control charts with stages, also sometimes called before/after control charts.

…
A Peek Inside Doctors’ Notes Reveals Symptoms of Burnout

‘Clinician burnout is a critical issue to understand and address,” says Mohsen Bayati, a professor of operations, information, and technology at Stanford Graduate School of Business. The condition is thought to affect nearly half of all U.S. doctors, at a cost of about $4.6 billion annually due…

Healthcare Cybersecurity

Cybersecurity has become increasingly critical in the digital age as organizations across all sectors face growing threats from cybercriminals.

Imagine that hackers breached a small healthcare practice through “phishing”—sending a scam email and gaining access to sensitive patient…

more articles
MDIC Presents the Accelerate Sustainable Capability Pilot Study
Raising the bar for quality standards in medical devices
Olympus Presents VISERA S
New imaging platform supports patient comfort, improved diagnostics, streamlined workflow
NIST Rebuilds World-Class UV Calibration System
Applications range from pandemics to pedicures
ZEISS Expands Innovation Hub Dresden
Strengthens research activities in the life sciences and health sector
TRIMEDX Introduces Real-Time Location System GeoSense
Provides comprehensive visibility to medical device inventory
MasterControl Launches Innovative Electronic Logbook Software Solution
Digital platform allows organizations to build, issue, execute, and review logbooks electronically
ETQ, Illumina: ‘How to Ensure Quality and Compliance in a Changing Landscape’
At ASQ World Conference on Quality and Improvement, San Diego, May 13
Olympus Announces FDA Clearance of RenaFlex
Company’s first single-use flexible ureteroscope for diagnostic and therapeutic procedures
Mettler-Toledo Showcases World-Class Product Inspection Systems at Interphex
Javits Center, New York, April 16–18, 2024
MasterControl Launches Advanced Quality Event Management Software
Recognized among early adopters as a leading innovation for the life sciences industry
Canon Medical/Digital Radiography Releases Clinical White Paper
Study of intelligent noise reduction in pediatric study
more news
      

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