Briefs: Medical
Neither the MDR nor Annex XVI are new. Nevertheless, the entry into force of the common specifications now presents a new situation for manufacturers of devices without an intended medical purpose.
From the Editor: Materials
Written by Katie Falcone, Scientific Support Manager, Datwyler, this article addresses the dangerous implications of micro material contamination.
Briefs: Medical
The EPA issued two separate proposals earlier this year covering the use of EtO for device sterilization: the National Emission Standards for Hazardous Air Pollutants and the preliminary interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act.
News: Regulations/Standards
The Performance Review Institute (PRI) has launched a new service designed to help companies improve manufacturing and quality management and improve...
News: Regulations/Standards
TÜV SÜD has received approval as a UK Approved Body (UKAB) for medical devices. With this approval, medical device manufacturers can implement UKCA certification for the UK market and...
Briefs: Medical
Thanks to artificial intelligence (AI), augmented reality (AR) has long shaped product development across a variety of areas, including the medtech industry.
News: Medical
An agreement reached by the UK and EU regarding the Windsor Framework brings changes to the Northern Ireland regulatory landscape. The agreement , in principle, was reached...
News: Regulations/Standards
The Performance Review Institute (PRI) has expanded its management systems certification portfolio through the acquisition of SRI Quality System Registrar. SRI is...
Trivia: Physical Sciences
It's March Madness! What organization was founded by a small group of physical educators and physicians who recognized that health problems were associated with certain lifestyle choices, especially smoking and lack of...
Supplements: Manufacturing & Prototyping
In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
Trivia: Physical Sciences
In November 1848, what was the first medical school to open for women?
Trivia: Regulations/Standards
In July 1965, what landmark amendment was passed that helped drive medical innovation and improve the quality of healthcare?
Trivia: Medical
At the turn of the 19th century, what industry was so dangerous that surgeons became specially trained to address the unique injuries of its employees?
Supplements: Test & Measurement
In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
Technology Leaders: Materials
Modern evaluation of biocompatibility uses a risk-based approach.
Features: Regulations/Standards
Bring your project from the process development phase of manufacturing to a fully validated one.
From the Editor: Connectivity
New best practices for understanding medical device security.
Supplements: Test & Measurement
In our winter edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
Products: Regulations/Standards
Linear stepper stages, tubing, Bluetooth modules, and more.
Features: Regulations/Standards
A robust, optimized mechanical testing program is essential to successful quality control testing.
Supplements: Tubing & Extrusion
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
From the Editor: Design
FDA has created a “Catalog of Regulatory Science Tools,” in which it provides a comprehensive list of peer-reviewed resources for medical device developers.
Features: Automotive
The "Evolving To MedDev" 2021 digital event will provide automotive and aerospace companies with practical information about how they can enter into the medical device supply chain.
Features: Test & Measurement
While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.
From the Editor: Medical
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
Briefs: Medical
The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
Products: Medical
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
Features: Regulations/Standards
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
From the Editor: Regulations/Standards
FDA has issued multiple emergency use authorizations, loosened regulations for telemedicine, and eased the requirements for production...