Articles By Eric Larson
-
07.08.25 -- Cleaning: Understanding Populations And Sample Sizes
7/8/2025
07/08/25 Med Device Online Newsletter
-
Cybersecurity Risk Management In Medical Devices: Practical Implementation Of FDA's 2025 Final Guidance
7/7/2025
The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025.
-
Designing Wearables That Are Truly Patient-Centric
7/7/2025
There’s a distinct need to create wearables that interweave seamlessly into an individual’s lifestyle, encouraging adherence and gathering long-term, accurate diagnostic data.
-
07.05.25 -- June's Most Popular Articles & Solutions
7/5/2025
07/05/25 Med Device Online Newsletter
-
Composable App Suite For Agile Operations
7/3/2025
Learn how a low-code, no-code platform can revolutionize frontline and manufacturing systems, enabling rapid solution development in weeks or months, not years.
-
Brazil's Regulatory Revolution: How New Laws Are Transforming Medical Device Clinical Trials
7/3/2025
Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape.
-
Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices
7/3/2025
Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.
-
Outset Medical: A Digital Transformation Success Story
7/2/2025
Discover how manufacturers like Outset Medical are using modern digital platforms and bottom-up strategies to boost productivity, agility, and quality in next-generation manufacturing environments.
-
How To Drive Change In Regulated Industries
7/2/2025
Discover how Dentsply Sirona embraced digital transformation to overcome legacy system challenges, boost efficiency, ensure compliance, and empower innovation through intuitive, code-free solutions.
-
Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification
7/1/2025
A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.