Regulatory and Compliance

GE Recalls Nearly 1,000 Diagnostic Imaging Systems Due to Detachment Risk

The recall was prompted by an incident in which the top detector of a Millennium Nuclear Medical System detached and fell onto the detector below.

FDA Warns Against Off-Label Use of Implantable Pain Pumps

FDA is alerting doctors and patients about the risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices.

8 Things You Should Know about the EU MDRs

Respondents to a recent survey on the new EU regulation raise some concerns about readiness. Are you prepared?

Should You Develop Your Own Material Specification and Skip ASTM’s?

Otherwise, there may be random impurities you may have to accept.

Halfway to the New European Medical Device Regulation, U.S. Manufacturers Feel the Pinch

It's the halfway point for the three-year transition period between the European Union’s old directive for regulating medical devices, and the new Medical Device Regulation.

Applying Quality Management Best Practices for Medtech

A look at how one medical device manufacturer automated quality management along with ideas on how shared intelligence can drive quality from the shop floor to the top floor.

FDA Congratulates Itself on Apple’s New Medical Apps

The agency is encouraging innovation in digital health. But is software really so fundamentally different from hardware that it can’t be regulated in the same way?

Continuous Quality: FDA’s Goal for the Case for Quality Program

Industry and FDA are working together to promote actual quality improvement, not just compliance to regulations.

SEC Strikes Again: Stryker Coughs Up $7.8M to Settle FCPA Violation Charge

This is the second time SEC has accused Stryker of violating the Foreign Corrupt Practices Act.

Can a Device Be Safe and Effective When FDA Recommends to Not Use It?

Medical device safety and effectiveness remain challenging principles to define and enforce.

Single-Touch Labeling: The Answer to EU MDR?

A single-source approach could eradicate data duplication, inconsistencies, and costly human error.

Are You Really Ready For MDR?

Audrey Turley, of Nelson Labs, will speak at Medical Design & Manufacturing Minneapolis about biocompatibility issues related to medical devices including the move to more in vitro testing and the 2020 deadline for the new European Medical Device Regulation.