RAMS 2.5 offers expanded medical device and IVD market coverage, plus new Smart Builder tools for European compliance

EMERGO by UL has formed a strategic alliance with medical device quality management system software...

Emergo by UL has launched 510(k) Builder, a new software tool supporting streamlined generation of...

Members of the HFR&D team appeared at the inaugural Healthcare Robotics Engineering Forum in Santa Clara, California.

Cytotron® qualifies for FDA Breakthrough Devices Program

Incorporating human factors engineering (HFE) into medical device development is more than a regulatory requirement...

2019 RAPS Convergence conference examined issues such as CER and clinical data management challenges

Emergo by UL has rolled out an enhanced version of its Regulatory Affairs Management Suite...

The Korea Medical Devices Industrial Cooperative Association (KMDICA), a South Korean medical device industry association,...

On October 11, EMERGO by UL Human Factors Research & Design (HFR&D) hosted an open house for clients, the Chicago tech start-up community, and employees to formally open its new Chicago Studio.

EMERGO SUMMARY OF KEY POINTS: Australia’s Therapeutic Goods Administration (TGA) plans to begin accepting certifications and approvals from additional foreign medical device regulators in addition to European CE Marking from market applicants. TGA will recognize registrations and certifications from US FDA, Health Canada, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) and Medical Device Single Audit Program (MDSAP) auditing organizations. Australian market applicants may leverage approvals and registrations from these agencies for expedited TGA premarket reviews.