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Elemis Bet on Formula 1, and It’s Paying Off

2 months 3 weeks ago

The skin care brand made an unconventional decision to offer spa and skin care treatments Grand Prix paddocks around the world, and this year it's going even bigger.

Tianwei Zhang

From Prototype to Production: Building a Validation Strategy That Scales with Manufacturing Volume

2 months 3 weeks ago

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?

The post From Prototype to Production: Building a Validation Strategy That Scales with Manufacturing Volume appeared first on MedTech Intelligence.

Rich West

Managing AI in Medical Technology: From Innovation to Compliance

2 months 3 weeks ago

Companies developing or deploying AI systems now face increasing scrutiny around risk classification, transparency and lifecycle governance. An AI management system (AIMS) aligned with ISO/IEC 42001 provides a structured way to address these challenges while significantly improving efficiency, quality, and innovation outcomes — and ensuring AI system are  effective, safe, compliant, and trustworthy.

The post Managing AI in Medical Technology: From Innovation to Compliance appeared first on MedTech Intelligence.

Rich West

Seven Things Every Medical Device Manufacturer Must Know Before Integrating AI

2 months 3 weeks ago

No longer a horizon technology, Artificial Intelligence in healthcare has reached a level of real-world performance that makes clinical value demonstrable at a critical time in healthcare – a time of clinician shortages, backlogs, and rising costs that have made access to treatment a challenge.

The post Seven Things Every Medical Device Manufacturer Must Know Before Integrating AI appeared first on MedTech Intelligence.

Rich West

From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market

2 months 3 weeks ago

Many challenges of designing and validating pediatric digital health devices are over-looked across developmental stages. Regulatory strategy, human factors, software architecture, and algorithm performance are critical consideration in dynamic patient populations.

The post From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market appeared first on MedTech Intelligence.

Rich West