FAIs: When do you use conventional versus digital inspection methods?

Tony Holtz, Proto Labs First article inspections (FAIs) can be time-consuming and costly, but they are a necessary step in getting medical devices from product design to production. Medical device manufacturers are likely familiar with the process, although most leave it to suppliers to handle. Even if that is the case, device makers should get

Toxikon showcasing preclinical testing services at DeviceTalks Boston

Toxikon is a preclinical Contract Research Organization (CRO) located in an FDA registered and ISO 17025 accredited laboratory facility in Bedford, Mass., and a second European lab operation in Leuven, Belgium. The company contracts and partners with biotech, pharmaceutical and medical device industries to deliver product development services from concept to final product. Its professional

Jordi Labs touting testing services at DeviceTalks Boston

Jordi Labs provides contract analytical services with a special emphasis on chemical identification and liquid chromatography products.  Customers in nearly all industries are benefit from its columns and packing media products worldwide. Featured services: E&L studies, particulates and residue analysis, polymer analysis Extractables and leachables studies: Performing an Extractables and leachables (E&L) study is an important part of verifying

Micronet Enertec wins $650,000 medtech testing systems contract

Micronet Enertec Technologies (Nasdaq: MICT) said today that its wholly-owned Enertec Systems 2001 subsidiary, Enertec Systems 2001 has secured a $650,000 purchase order from an undisclosed Fortune 50 multi-national medical device company. The purchase order involves Enertec creating fully automated testing systems for medical calibration devices treating heart rhythm disorders. It’s the largest order Entertec

Could this new assay reduce the need for animal tests?

American Preclinical Services has developed a novel assay that its creators think could replace the thromboresistance animal tests for medical devices – which use dogs, sheep and pigs. Mark E. Smith, American Preclinical Services Blood-contacting medical devices and the materials from which they are constructed must meet stringent safety criteria prior to regulatory approval for

Nexus IE creates catheter coating test system for BioInteractions

Product consultancy Nexus Intelligent Engineering (Nexus IE) has designed and developed a fully automated catheter coating test system for medical device coatings supplier BioInteractions. Nexus IE (Witchford, U.K.) designed the BIOFriC 1000 fto measure the coefficient of friction of coated catheters. The test system could have uses in both  medical R&D laboratories and product manufacturing

3D printed living tissue may eliminate animal testing

English scientists have figured out a way to 3D print cells grown in a laboratory to create living structures. Researchers at the University of Oxford and the Center for Molecular Medicine at Bristol were able to showcase how human and animal cells could be printed into high-resolution tissue constructs. Being able to control the position

ADM Cleveland: Here are some top medtech manufacturing highlights

Updated March 31, 2017 The inaugural Advanced Design and Manufacturing conference and expo in Cleveland showcased some of the medical device industry’s top design and manufacturing technology over the past week. From manufacturing depression treating machines to dry ice cleaning machines, here are some notable exhibitors from the show. Next >> [Want to stay more on top

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This brain-sensing headband gives scientists an idea of how brains age

A wireless brain-sensing headband is benefiting more than just the consumer. The valuable data that the headband creates and collects is shedding new light for neuroscience researchers on what happens to our brains as we age. Muse is a wearable device that helps users meditate. It guides the user through meditation by changing the sounds

Aved boasts 100% testing of medical cable assemblies

Aved Electronics announced Tuesday that it has introduced a new, comprehensive medical cable testing capability that provides enhanced traceability per ISO 13485 quality management for medical devices. Aved Medical Cable & Wire Harness Assembly Services utilize a broad range of automated wire processing equipment for wire from 30 Ga to 1 KC mil and virtually

What is validation and why is it perceived as so complex?

Oscar Ford/Business Development Manager/Preh IMA Automation Evansville Inc. Many perceive validation as complex, ill-defined, and fear-inducing. The question is, “Why?” Why does the mere mention of the word “validation” stimulate fear and anxiety for some people? The following might provide some insight into this perception:  In many cases validation is not consistently described and understood because

What does the FDA say about validating software?

Kevin Ballard/Director of Software Validation/MasterControl Software validation is required by law for companies that operate under the purview of the FDA and EMA. Companies must validate their systems (such as those for quality management and compliance) to comply with a number of regulations including 21 CFR 11, 21 CFR 210-211, 21 CFR 820, 21 CFR 600, and 21

Scientists tissue engineer human intestines and functioning nerves

Scientists report in Nature Medicine using human pluripotent stem cells to grow human intestinal tissues that have functioning nerves in a laboratory, and then using these to recreate and study a severe intestinal nerve disorder called Hirschsprung’s disease. Published online Nov. 21, the findings describe an unprecedented approach to engineer and study tissues in the

Cleveland Clinic unveils its picks for the medical innovations most likely to be game changers

Smart cars that reduce accidents and injuries. Immunotherapy that helps kids beat cancer without chemo. Stents that harmlessly dissolve when their work is done. These are some of the innovations that will enhance healing and change healthcare in the coming year, according to a distinguished panel of doctors and researchers. Cleveland Clinic today announced the

Banner Engineering expands Q4X laser distance sensor offering with compact, flush mount models

Banner Engineering has added flush mount housings to its rugged series of Q4X laser distance measurement sensors. The new flush mount configuration offers a more compact housing to expand applications and increase mounting flexibility in constrained spaces. “The new flush mount configuration of the Banner Q4X sensor provides more integration possibilities and greater installation flexibility,