Finding a Manufacturing System Upgrade to Match In-House Innovation

Radiation medicine pioneer Elekta is growing fast. In anticipation of regulatory changes requiring more documentation and labeling, the company implemented a manufacturing...

Exploring Valve Technology Requirements Under the New MDR

Although the pandemic has delayed the MDR’s validation date, it has not diminished the importance of this new regulation.

First, Do No Harm: Changing Strategies to Prove Your Medical Device Is Safe

Modern evaluation of biocompatibility uses a risk-based approach.

Suppliers Keep Pace with Changing Dialysis Needs and Fast-Moving Regulatory Environment

With longer lifespans and aging populations worldwide, the need for and importance of dialysis technology will only grow.

Mastering the UKCA Compliance Challenge

Deadlines are approaching for compliance.

Switch-Mode Power Supply (SMPS) Emissions Filtering: Attenuation vs. Leakage Trade-Off

This relationship is important to understand when developing the end system.

When Every Second Counts … Important Considerations for Respiratory Ventilator Design

Ventilators are mission-critical to sustaining life and require a robust design to ensure they maintain the necessary up-time for patient care.

Harnessing the Power of Ultrasonic Precision Cleaning for cGMP Compliance

Removing organic contaminants and reducing bacterial and viral loads in medical device manufacturing.

Safer Helmets Reduce Potential for Traumatic Injury

“Seventy-five percent of all fatal motorcycle accidents globally involve brain injury, with rotational forces acting on the brain being the primary cause of death,” According to NHTSA. By...

Good Design Controls Are Critical to Avoiding FDA Issues

Medical device companies recognize that having an emphasis on design controls helps to assure good design and engineering practices that yield high-quality solutions. This is critical...

Implementing IEC 62304 for Safe and Effective Medical Device Software — PART 1

FDA’s introduction to its rules for medical device regulation states: “Medical devices are classified into Class I, II, and III. Regulatory control increases...