FDA’s New Program Puts Life-Saving Technologies on Fast Track to Approval
If all goes as planned, patients who suffer from life threatening or irreversible debilitating conditions will have faster access to new technologies.
Device Manufacturers Still Grapple with Recall Risks and Next Steps
Industry needs to understand that they do not classify a recall, the agency classifies it, advises former FDA official Steven Niedelman.
Medical Devices in Canada: How to Enter the Market
When launching a new product, manufacturers may want to consider Canada first.
Unannounced Inspections by Notified Bodies a ‘Principal Challenge’ for 2015
With decreasing prices and increasing regulation, many UK medical device businesses are looking to emerging markets for growth. However, compliance issues are also problematic in those territories, according to a recent study from life science consulting firm Maetrics.
Who Should Hold Your Product Registrations in Asia?
Most international medical device companies work with Asian distributors to sell their products in the local marketplace. Finding, qualifying, and signing up the right distributors is an important job since these distributors will sell your products locally. Another key aspect is who holds the registration.
Boston Scientific wins CE Mark and FDA Approval for Thinner, Leadless ICD
Using subcutaneous leads, rather than leads threaded through blood vessels to the heart, the EMBLEM Subcutaneous Implantable Defibrillator model is 19 percent slimmer and projected to last 40 percent longer than the original S-ICD, according to the company.
FDA Issues Final Guidance on Reprocessing of Reusable Medical Devices
The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.
EU Notified Body Unannounced Audits and Your Suppliers
The most important part to remember about this recommendation document for unannounced audits is that it not only applies to medical device manufacturers, but also significantly includes their suppliers and subcontractors.
GE Healthcare Issues Warning on 30 Years of MRI Scanners
The company has issued a warning covering 30 years of its MRI scanners, based on a human error safety incident in India.
Using Root Cause Analysis for Powerful Defect Prevention
Many product development teams use root cause analysis and root cause corrective action to identify the origin of defects in their development processes and prevent them from recurring. Though these can be complicated and time-consuming, automated product development solutions can help reduce the time spent on RCA, RCCA, code reviews, and other quality improvement efforts.
