Search Results for 'unique device identification'
-
The Economics of a Sound Regulatory Strategy
While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20
-
Materials
A Matter of Substance: Medical Device Materials
Medtech manufacturers are leveraging cleaner, more lightweight materials to meet increasing demand for home healthcare solutions and wearable devices.Michael Barbella, Managing Editor 03.04.20
-
Packaging & Sterilization
Anxious Undertones: The 2019 Year in Review
Despite a healthy U.S. economy and solid corporate growth, the medtech industry was wracked with worries in 2019.Michael Barbella, Managing Editor 11.04.19
-
Compamed 2019 Preview Report
Experience the full range of supplier expertise for the medical technology industry.Online Exclusives Klaus Jopp 10.08.19
-
TÜV Rheinland Becomes a Notified Body for the New Medical Device Regulation
New regulation came into effect May 2017.TÜV Rheinland 10.01.19
-
FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting
Among other changes, the agency formally ended the Alternative Summary Reporting (ASR) Program.U.S. Food and Drug Administration 06.24.19
-
Reed Tech Introduces Reed Tech SingleSource for Medical Devices Supporting Global UDI Requirements
The SingleSource system is a Reed Tech-hosted, online repository with governance and controls for data quality, data integrity, and data security.PR Newswire 05.06.19
-
Surgical
FDA Updates Medical Device Safety Action Plan to Enhance Post-Market Safety
The agency aims to enhance medical device safety net and focus on several women's health devices.Scott Gottlieb M.D., Commissioner; Jeff Shuren M.D., Director of the Center for Devices and Radiological Health, U.S. Food and Drug Administration 11.21.18
-
Contract Manufacturing
Automating the Manufacturing Orchestra
Sophisticated welding tools, robotic systems, DFM, and Industry 4.0 address medtech assembly challenges.Mark Crawford, Contributing Writer 10.16.18
-
FDA Releases Medical Device Safety Action Plan in Effort to Modernize Approach
Effort aims to enhance and modernize the FDA’s approach to medical device safety and innovation.Scott Gottlieb, M.D. 04.18.18
-
121nexus Appoints Executive Vice President and Chief Operating Officer
New executive also will have a seat on the company's Board of Directors.Business Wire 04.06.18
-
The New MDR: Piling on the Pressure or Opening the Doors to Opportunity?
Early MDR adopters could peel away market share from those companies slower to respond.Online Exclusives Peter Rose, Managing Director, Maetrics 03.19.18
-
Packaging & Sterilization
Positive Identification: An Examination of Converting, Labeling, and Printing
A product’s label might be an afterthought, but challenges can stall a new product launch.Mark Crawford, Contributing Writer 03.15.18
-
121nexus Launches Free Scan App to Improve Medical Device, Pharmaceutical Supply Chain
First app to verify and “open up” GS1 and Unique Device Identification barcodes for healthcare products.Business Wire 12.13.17
-
Packaging & Sterilization | Testing
Packaging Validations—Looking Beyond ISO 11607
...Christopher Scott, Vice President, Eurofins Medical Device Testing 10.05.17
-
Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical
Top 10 Challenges of the New MDR
Learn what the most pressing issues are in the EU’s Medical Device Regulation and find out how to tackle them.Online Exclusives Peter Rose, Managing Director Europe, Maetrics 06.22.17
-
Testing
Discussing the UL/Emergo Merger: A Q&A
Representatives from both firms speak about the transaction, the expected benefits, and what’s ahead.Online Exclusives Sean Fenske, Editor 06.20.17
-
Packaging & Sterilization | Software & IT
NHS Barcoding: A Key Step Toward UDI
Compliant companies stand to gain a competitive edge over others within their sector.Online Exclusives Peter Rose, Managing Director, Maetrics 05.17.17
-
Laser-Markable Compounds From RTP Company Provide Viable UDI Option for Medtech
Medical devices made from the company’s laser-markable compounds can be laser marked easily and efficiently.RTP Company 03.30.17
-
Diagnostics | Digital Health | Electronics | Patient Monitoring | Software & IT
Software’s Coming of Age
Successful software integration is the key to reaching higher quality and lower costs.Mark Crawford, Contributing Writer 03.07.17
-
TransPerfect and 121nexus Update the EnCompass System for Medtech Manufacturers
The updated system is designed to cut labeling cost, risk, and turnaround by 50 percent.Business Wire 01.06.17
-
R&D & Design | Software & IT
Loftware Partners with PTC, Announces New Medical Device Solution
Solution streamlines entire label process, offers operational control and improves quality.Loftware Inc. 10.24.16
-
Materials | Packaging & Sterilization | R&D & Design | Software & IT | Testing
5 Considerations to Ensure UDI Compliance
With another deadline just around the corner, device makers need to review their UDI strategy.Online Exclusives Steve Cottrell, President, Maetrics; Madris Tomes, CEO, Device Events 09.16.16
-
Materials
How Europe Can Prepare for Unique Device Identification (UDI)
From a European perspective, manufacturers should take full advantage of becoming UDI compliant as quickly as possible.Online Exclusives Steve Cottrell, President, Maetrics and Madris Tomes, CEO, Device Events 08.15.16
-
Tubing & Extrusion
FDA Releases Plan for Unique Device Identification System The U.S. Food and Drug Administration (FD
...07.24.12
-
Evangeline Loh and Stewart Eisenhart Slowly but surely, the Unique Device Identification (UDI) Sy
...10.12.11
