Allergan, Ideal Implant Hit with FDA Warning Letters for Breast Implants
The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
Tag Archives: compliance
Essential Data Preparations for AI
Smart process automation promises to cut complexity and transform product traceability in the medical device industry. However, its potential relies 100% cent on having good, reliable data on which to draw.
GS1 Updates Global Model Number Identifier For Use as a Basic UDI-DI to Meet EU MDR Requirements
A recap of a recent effort involving a small group of AIDC experts in devising a data integrity scheme suitable for protecting a new device identifier used in modern healthcare applications against mis-keying. It presents the group’s undertakings in researching solutions to ensure identifier integrity, the challenges encountered, and how a more complete understanding of the constraints of the intended application led to a departure from the initial design and resulted in the elegant solution that exists today.
How Effective Collaboration Can Expedite Medical Device Design
Medical device companies are committing significant resources to the fight against Covid-19. Collaboration tools can help expedite product design while supporting evolving compliance standards.
Illuminating the Shadows: How Unveiling Five Blind Spots Can Transform Business
Whatever the short- and longer-term fallout of COVID-19, organizations will need to come back fighting—with new tools at their disposal and ready to raise their game.
Compliance Date Approaching for FDA Unique Device Identifiers
Timely compliance will ensure that your products will not be considered misbranded.
How to Get More Mileage Out of Your Electronic IFU
Taking a bare-minimum approach to meeting the eIFU requirements of EU MDR could mean missing an opportunity to improve transparency in healthcare. Here’s how to use eIFU to provide stakeholders with greater confidence and clarity in medical devices.
FDA Operation Prevented Illegal Shipments of Products from Entering U.S. Market
The enforcement operation kept nearly 500 shipments of illegal drugs and combination devices from the hands of consumers.
EU MDR: Will You Be Able to Sell Your Medical Device in Europe after May 26?
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
How We Created an Orchestrated Approach to Healthcare Cybersecurity Assurance
The goal is to establish a baseline of cybersecurity hygiene and assurance for devices that are part of the national critical infrastructure software supply chain.
