Securing the Medical Supply Chain: How Quality Testing Strengthens National Resilience
When the U.S. Department of Commerce announced a new Section 232 National Security Investigation into imports of personal protective equipment […]
Medical Device Safety
Validating Reusable Medical Devices: Sterility, Material Degradation, and Safe-Life Assessments in a Circular Healthcare Future
Healthcare and sustainability are converging in powerful new ways. Around the world, hospitals and manufacturers are rethinking their environmental impact
MedTech AI Regulation in the U.S., EU, and UK: How Testing Labs Must Evolve to Support AI-Enabled Medical Devices
Artificial Intelligence (AI) has moved from being a futuristic concept to a practical backbone of modern medical technology. From diagnostic
Shutdown Signals: How the U.S. Government Shutdown Impacts FDA Oversight — and Why Independent Testing Matters More Than Ever
In times of political gridlock, few ripple effects are as consequential as those caused by a federal government shutdown. While
When Trade Policy Disrupts the Supply Chain: How Medical Device Testing Adapts Under Tariff Pressure
The medical device industry thrives on global collaboration. Components may be designed in Germany, molded in Malaysia, sterilized in the
The Hidden Risks of Medical Equipment Rentals: Why Validation and Sterility Assurance Matter More Than Ever
In an era where efficiency and flexibility dominate healthcare operations, hospitals across the United States are increasingly turning to medical
Why Medical Device Experts Are Challenging Traditional Chemical Testing — And How CMDC Labs Helps Bridge the Gap
Introduction Medical devices—from surgical instruments and implants to diagnostic equipment—touch millions of lives every day. Their safety and reliability are
Ophthalmic Devices and the Hidden Risks of Regulation & Safety
The global medical device industry is under constant regulatory pressure, but few categories face the unique challenges of ophthalmic devices.
FDA Warning: Unreliable Third-Party Data in Medical Devices
In September 2025, the U.S. Food and Drug Administration (FDA) issued a cautionary update to the medical device industry: unreliable
FDA Declares PFAS Polymers in Medical Devices “Safe and Currently Irreplaceable”: What That Means—and What It Doesn’t—for Medtech and Hospitals
When most people hear “PFAS,” they think headlines about “forever chemicals,” drinking-water advisories, and state bans on PFAS-containing consumer goods.
Hidden Risks in Reusable Medical Devices: Cleaning Challenges You Can’t See (Until It’s Too Late)
Hospitals and medtech manufacturers know the stakes: a single reprocessing failure can cascade from a quality glitch into a patient
Evolving Sterilization Standards: What Device Labs Must Validate Now
In March 2025, the FDA expanded its recognized consensus standards database to include updated sterilization guidance documents from AAMI (Association
13% at Risk: How Testing Labs Can Support U.S. Medtech Amid Tariff Headwinds
Recent trade developments have raised serious concerns for the U.S. medical device industry. With tariffs increasing sharply on imports from
Sterile Supply vs. Emissions: How Labs Must Adapt to EtO Relief
On July 17, 2025, the White House issued a proclamation that affects the entire medical device sterilization industry. It gave
Sterility Isn’t Optional: What the Latest FDA Recall of Surgical Mesh Teaches About Medical Device Testing
On July 5, 2025, the U.S. Food and Drug Administration (FDA) announced a Class II recall of Ethicon’s PROCEED Surgical
The Role of Finite Element Analysis (FEA) in Custom Implant Design and Preclinical Testing
The field of medical implants has revolutionized patient care, enabling doctors to treat a range of medical conditions with personalized
Standardizing In Vitro Testing Protocols: Strategies for Improving Reproducibility and Cross-Lab Comparability
In vitro testing is an essential part of the scientific and medical fields, used in everything from drug discovery and
How Custom Implant Testing Helps Engineers Validate Medical Device Safety
Introduction The development of custom implants for medical use is a complex, multifaceted process that involves a range of engineering
Bioburden Testing, Medical Device Safety, Pharmaceutical Testing, Product Efficacy
The Role of Bioburden Testing in Quality Control: Why Regular Monitoring Is Essential
Bioburden testing plays a crucial role in ensuring the safety, efficacy, and overall quality of products, particularly in industries like
Understanding the Regulatory Requirements for Custom Implant Testing: A Step-by-Step Compliance Guide
Custom implants, such as orthopedic implants, dental implants, and prosthetics, play a crucial role in improving the quality of life
From Lab to Market: How In Vitro Testing Helps Validate Product Safety and Efficacy Before Clinical Trials
In the development of new drugs, medical devices, and biotechnology products, ensuring the safety and efficacy of a product before
The Future of FDA Regulations: What Companies Need to Prepare for in 2025
The Food and Drug Administration (FDA) plays a critical role in protecting public health by ensuring that food, drugs, medical
The Science Behind Antimicrobial Surface Testing: Methods and Industry Standards
In today’s world, antimicrobial surfaces have become a vital part of many industries, from healthcare and food production to consumer
How to Validate Sterility Testing Methods for Pharmaceuticals and Medical Implants
In the pharmaceutical and medical implant industries, sterility is a critical factor in ensuring patient safety and product efficacy. The
Mechanical Testing for Custom Implants: The Science Behind Durability, Fatigue Resistance, and Structural Integrity
In the realm of medical implants, ensuring the long-term safety and effectiveness of devices such as joint replacements, dental implants,
Innovations in In Vitro Testing: How Advanced Screening Methods Are Transfroming Drug and Medical Device Development
In recent years, the landscape of drug development and medical device testing has been significantly shaped by the innovations in
How to Navigate the Evolving Landscape of Medical Device Regulatory Compliance
Introduction In the fast-paced, highly regulated medical device industry, ensuring compliance with ever-changing laws, standards, and regulations is a constant
How Antimicrobial Testing Helps Validate Product Claims and Prevent False Advertising
Introduction In today’s competitive market, consumers are becoming increasingly cautious about the products they purchase, particularly those claiming to offer
The Importance of Chemical Analysis in Ensuring Product Safety and Regulatory Compliance
Introduction In the modern global marketplace, product safety and regulatory compliance have become essential elements of manufacturing, distribution, and retail
Best Practices for Bioburden Testing in Medical Devices: Ensuring Compliance and Patient Safety
Introduction In the world of medical devices, safety and compliance are of paramount importance. The potential risks of introducing harmful
Ensuring Product Safety with Microbiological Testing: How to Detect and Prevent Contamination in Pharmaceuticals, Food, and Medical Devices
Introduction Product safety is a primary concern in the manufacturing of pharmaceuticals, food, and medical devices. Contamination in any of
How Custom Implant Testing Ensures Biocompatibility, Durability, and Long-Term Performance in Patients
Introduction The development of custom implants has revolutionized the field of healthcare, offering personalized solutions for patients in need of
Overcoming Common Challenges in In Vitro Testing: How to Ensure Accuracy, Consistency, and Regulatory Compliance
Introduction In vitro testing, an essential process in drug development, medical device validation, and safety testing, offers significant advantages over
Cytotoxicity in Focus: Understanding Its Role in Medical Device Safety
In the dynamic landscape of medical device development, ensuring safety is paramount. One crucial aspect that demands meticulous attention is
