How to work with a preclinical contract research organization

When outsourcing medical device laboratory testing, knowing what the regulatory and business requirements are up front is critical to the success of your testing program. Amy A. Schade, Felice Randi LaMadeleine and J. Heléne Andersson, Toxikon Requests such as unusual application of technical or regulatory guidelines, shortened timelines, nonstandard study designs and custom reports are

Simplifying product testing and validation with fastener torque auditing

Capturing data during a product’s manufacturing process can help ensure the quality and consistency of that product. Here’s how that process plays out with fastener torque. Thomas Moore, Futek One of the scariest phases of product design is testing & validation. That’s when any unknown flaws or manufacturing defects will see the light of day.

Sterigenics parent company is now Sotera Health

Sterigenics International said today that it has changed the name of its parent company to Sotera Health, with Nelson Labs, Nordion and Sterigenics as Sotera’s three operating companies. The new name drew its inspiration from the name of the Greek goddess of safety, Soteria, and is meant to reflect the company’s commitment to global health.

Nelson Labs parent Sterigenics buys Toxikon’s European lab business

Sterigentics International is seeking to turn its Nelson Labs business into a global extractables and leachables lab testing platform through its acquisition of Toxikon’s European division. The purchase of Toxikon Europe, announced yesterday, represents a capabilities expansion when it comes to serving the pharmaceutical and medical device industries. Sterigenics’s Nelson Labs business will now offer Toxikon

Validation and testing: What you need to know

James Woods, Jordi Labs In an increasingly competitive medical device industry, it’s still important that validation and testing is done right. Here are four things to keep in mind. Medical device industry leaders these days are driving results at an ever-increasing pace. Amid patent limitations, intense competition and acute regulatory scrutiny, there’s a rush to

How Integer is creating cutting-edge disposable ortho surgical tools

With health providers increasingly demanding single-use devices, Integer successfully created disposable bone-cutting tools for its orthopedic device customers. Gary Victor, Integer Within healthcare today, there is a heightened focus on “value” – on the episode of care and the need to deliver improved patient care outcomes and lower overall costs. A related trend in the

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