FEATURED EDITORIAL
Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide
This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.
-
India’s Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 that will shorten manufacturing license timelines while preserving quality, safety, and performance requirements.
-
In June, Brazil's ANVISA released a batch of clinical trial petitions because its review deadline had expired without a decision. Take a closer look at what medical device companies should know.
-
Let's take a closer look at the scientific principles, technological progress, and translational hurdles defining the present state of microneedle research.
INDUSTRY INSIGHTS
-
Advancing Biopsy Device Performance Through Precision Overmolding And Assembly
Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.
Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.
Scaling point-of-care diagnostics requires integrating microfluidics, chemistry, and automated assembly early in development. Aligning these pillars reduces risk and speeds time-to-market.
Decisions made during clinical manufacturing have lasting consequences at commercial scale. This article examines how fill/finish equipment choices shape long-term flexibility, throughput, and operational continuity.
Effective particulate control in aseptic fill/finish operations requires coordinated design decisions spanning airflow configuration, static mitigation, transport mechanisms, and closure handling.
MED DEVICE ONLINE CONTENT COLLECTIONS
Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
More Content CollectionsLATEST HEADLINES
- Nordson MEDICAL Introduces The New Divert™ ULTRA Line Of Ultra-High- Pressure Stopcocks For Demanding Medical Applications
- Curi Bio And Battelle Announce Strategic Partnership To Accelerate The Adoption Of NAMs In Neuromuscular Pharmacology
- NeuroLife® Launch Brings Non-Invasive Technology Aimed At Restoring Hand And Arm Movement After Stroke And Spinal Cord Injury
- Discover Medbio's Advanced Manufacturing Solutions For Injectable & Drug Delivery Device
- Discover Medbio's Advanced Manufacturing Expertise for Robot-Assisted Surgery At DeviceTalks Boston 2026
- Discover Medbio's End-to-End Medical Manufacturing Expertise & Scalability At INTERPHEX 2026
- Lifecore Biomedical Signs New Agreement With Indomo To Support Innovative Drug/Device Combination Acne Treatment
- Strategy Beyond The Bench: Eurofins Launches New U.S. Consulting Chapter In Medtech Strategy & Policy