Contact Support

The engineer behind the first CT scan

When we think about medical devices, we may not take much time to consider when they were first invented. It may be hard to imagine that October 1, 1971, was 50 years ago but many of today’s most used medical devices were invented in the last 100 years including the first computed tomography image or […]


Electronic nose can distinguish millions of scents

Did you know the human nose has an estimated 400 scent receptors and can distinguish millions of different smells? Trying to replicate this seems almost unfathomable, but one engineer is finding a way to benefit the environment, law enforcement, and even the military. Through a grant from the National Science Foundation’s Center for Bioanalytical Metrology […]


Device taps brain waves to help with communication

Communication and the ability to communicate are often taken for granted, but not so for a person that has been without this ability.  “In a medical first, researchers harnessed the brain waves of a paralyzed man unable to speak—and turned what he intended to say into sentences on a computer screen.” While it will take […]


Labeling Regulations by Industry

Managing the requirements and following the guidelines when it comes to regulatory compliance labeling can be a challenge. Especially for organizations in the chemical, medical, and food & beverage industries. It’s become a higher priority for companies with adherence to strict and evolving policies that have placed additional  demands for compliance labeling. Chemicals: Global harmonized […]


EU MDR Compliance Labeling

The European Commission legislation is introducing new compliance requirements on medical devices and creating completely new medical device regulations (MDR). Following in the footsteps of the Food and Drug administration of the US, EU has decided to adopt the Unique Device Identifier (UDI) for all medical devices and In Vitro Diagnostics (IVDR). This will be […]


How do I manage all the projects that I have and still get compliant on UDI?

UDI requirements for class 3 and class 2 devices are now behind you, but the compliance standards continue to emerge and you must maintain the ones you have already completed. Maybe your organization is impacted by all three (3) UDI class distinctions, or MDR (European UDI) standards, or you  have additional requirements to maintain these […]


FDA UDI Class I

Several dates for UDI compliance have been postponed: •         Class I and unclassified devices – 24th of September, 2020 •         Direct Marking of Class I and unclassified devices – 24th of September 2022 Low-risk devices are required to follow the UDI ruling two years later than it was originally planned (24th of September 2018). Class […]


UDI Exceptions on Single Use Devices

Last week we discussed the extension the FDA has granted on the Unique Device Identifier (UDI) Class II Mandates. Similar to the extension there are also exceptions on single use devices that medical manufactures should be aware of. The exception states that if you put a (UDI) on the next higher level of packaging you […]


European Commissions (EU) latest revision for UDI

The European Commission (EU) announced its latest revisions to the proposed rule changes for unique device identification (UDI) requirements. The agreement has been in the development stage for the past year and the EU has now developed tighter rules for medical manufactures. These rules center on areas such as trace-ability and are designed to ensure […]


Medical Device Audit Preparation

Quality system audit schedules are typically published at the beginning of each year; however, internal auditing personnel may find themselves unprepared when actual audit dates approach. In such instances, companies undertake last minute preparations of checklists and audit questions that generally take months to develop. This can lead to a rushed audit process where corrective […]