FDA Cybersecurity Update Takes Aim at Medical Device Quality Systems
FDA is recommending comprehensive cybersecurity risk management programs and documentation consistent with device quality systems....
Sep 06 2022,
Regulations
EPA Provides EtO Update by Calling Out Sterilization Plants, Nodding to Future Pollution Rule
The agency said that its new analysis findings would inform a long-awaited air pollution rule that could have consequences for...
Aug 08 2022,
New ASTM Standard Focuses on Test Methods for SI Joint Implants
ASTM international is seeking participating manufacturers and test labs to support reproducibility requirements of the new standard....
Jul 27 2022,
MedTech is Unprepared for MDR Deadlines, Survey Highlights
MedTech Europe concluded there's an urgent need for immediate action to help keep needed medical devices available in Europe....
Jul 22 2022,
So, You Think You Have a Novel Device? Here’s What FDA Says.
Got a potentially noteworthy or novel device? Here are some tips to help determine the best regulatory submission pathway....
Jul 22 2022,
Understanding Process Validation Requirements for Orthopedic Products
Advice on how to Make Sense of the IQ/OQ/PQ alphabet soup....
Jul 11 2022,
Study Finds Tougher EU Regulations Force Companies to Eye U.S. Market
Medtech say they’ll begin to prioritize the U.S. market first....
May 23 2022,
EU MDR Poses Tough Decisions for Orthopedic Companies
Notified Bodies have recommended companies submit their applications 18 months in advance. That means manufacturers need to submit their MDR...
Apr 25 2022,
FDA Releases Computational Modeling and Simulation Guidance
FDA's guidance focuses on the credibility of CM&S in medical device submissions....
Jan 10 2022,
FDA Releases Potential Framework for Point-of-Care 3D Printing
FDA's discussion paper outlines scenarios in which hospitals might 3D-print devices and asks industry for comments. ...
Dec 15 2021,
Development and Lifecycle Management of Software as a Medical Device
Orthopedic companies that manufacture medical software products are required to manage the life cycle of their medical device software....
Oct 29 2021,
Defining and Regulating the Complex World of Software as a Medical Device
Global regulators are considering how to adapt to the fast-moving nature of software as a medical device technology. ...
Oct 11 2021,
FDA Opens Office of Digital Transformation to Streamline Data and Cybersecurity Efforts
FDA formally opened the office as part of a broader effort to modernize and strengthen its information technology, data management,...
Sep 20 2021,
New Warning from FDA: Sales of Unapproved Orthobiologic Products
FDA doubled down on its enforcement commitment for Human Cell and Tissue Products after its enforcement discretion ended in May....
Jun 22 2021,
FDA Details Plan to Restart Facility Inspections
FDA recently announced its plans to resume inspections by July. The agency is working through a backlog of 8,000 inspections...
May 25 2021,