TOP GUEST COLUMNS
1.
The Intersection Of ISO 13485 And ISO 14971 Under The Proposed FDA QMSR
By Edwin Bills and Christie Johnson
2.
3 Common Mistakes Using Gantt Charts For Medical Device Projects
By Eric Hinrichs, (retired), Ethicon, part of the Johnson & Johnson Medical Device Companies
3.
New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Medical Devices
By John Giantsidis, president, CyberActa, Inc.
4.
The Role Of Failure Mode In ISO 14971:2019’s Hazard-Based Approach
By Jayet Moon, author of the book Foundations of Quality Risk Management
5.
The FDA Regulatory Landscape For AI In Medical Devices
By Michele Buenafe, Jake Harper, and Andrew Gray
TOP ARTICLES
Change Control: Considerations For Medical Device Components
By Paul Priebe, Qosina Corporation
A New Mindset For Combination Product Development
By Asmita Khanolkar, Cambridge Pharma
Three Considerations When Introducing A New Medical Device
By Flexan
6 Steps To Simplify Software Validation
By Kevin Ballard, MasterControl
Measuring Cleanliness
By Michael Moussourakis, Jeff Phillips, Stacy Silverstein, Malcolm McLaughlin, Alconox
6.
What Is Micro 3D Printing?
By Christopher Hunt, Accumold
7.
Sterile Medical Package Inspection
By PTI Packaging and Inspection Systems
TOP WHITE PAPERS
The Dynamic Regulatory Environment Of Drug-Device Combination Products
By Diane Paskiet, West Pharmaceutical Services, Inc.
Selecting MLCCs That Meet The Requirements Of Medical Implantable Devices
By Knowles Precision Devices DLI
What Can The Medical Device Industry Learn From The Boeing 737 MAX 8 Crashes?
By Edwin L. Bills, consultant for Qosina Corporation
Manufacturing Transfers For Medtech OEMs: Part 1
7 Critical Factors For Predictable Quality In Medical Device Manufacturing
By Matt Knutson, Donatelle
Why Biological Indicators Survive A Validated Cycle
By Garrett Krushefski, Mesa Laboratories
Regulatory Evolution And Data Revolution In Medical Device Development
By Dassault Systèmes
TOP APPLICATION NOTES
Extruded Medical Tubing: Process Parameters, Equipment Play Critical Role
By Nordson MEDICAL
Continuous Microbial Air Monitoring In Cleanroom Environments
By Sartorius
Selecting The Best Pinch Valve For Your Application
By The Lee Company
Hostraform POM ECO-B: Proven Versatile, Easy, And Environmentally Sustainable
By Kevin Norfleet and Rob Haley, Celanese
Performance Of Bioprosthetic Heart Valves: Material Considerations
By Ben Kibalo, DSM Biomedical
Rejuvenating And Regenerating The Skin With Biodegradable Polymers
By Dr. Aleksandra Ćwil-Kaczmarek and Caroline Lauret, Evonik Health Care
TOP CASE STUDIES
Material Selection For Medical Device Manufacturability
By Medbio
Transforming Reusable Device To Single-Use Improves Patient Safety And Saves Costs
By Donatelle
The Development Of A Plastic Capillary Blood Sampling Device
By Carclo Technical Plastics
TOP PRODUCTS AND SERVICES
Non-Magnetic, High-Power RF Capacitors And Trimmers
Knowles Precision Devices DLI
Alba: A Breakthrough Solution For Biologics
Stevanato Group
Nitinol Components
Nordson MEDICAL
Orthopedic Structures
Secant Group
Smart Pump Module
The Lee Company
Forerunner Prototyping Services
MTD Micro Molding
TOP RESOURCES
A Guide To Medical Devices Quality Control And Testing
Sartorius
High Viscosity Formulations: Developing A ‘Human Solution’ To Autoinjector Design
SMC Ltd.
Prototype Plus: Design To Production, Simplified
Medbio
TOP VIDEO
What Are Canon's Linear Ultrasonic Motors All About?
Canon USA, Inc. Optoelectronic Components
TOP WEBINAR
Medical Device Manufacturing And RFID
HID
