In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...

Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the ...

Key factors propelling the growth of the medical suction devices market include the increasing prevalence of chronic respiratory diseases, such as COPD and asthma, and a rise in surgical procedures ...

Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that ...

In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more ... the research and development, the regulatory ...

"Seeing is believing," the founder of lab company Truvian told me. So I tried its tabletop blood testing device—which ...

The most common approval process ... regulatory submission, but the final regulatory approval will not be granted until IEC/IRB approval has been received. The Pharmaceuticals and Medical Device ...

Medical, legal, and regulatory review (MLR review ... GenAI tools can streamline the MLR process by tracking the reuse of previously approved materials and claims supported with appropriate ...

While most medical devices go on the market without clinical studies, high-risk ones that undergo pre-market approval need ... She said this regulatory process prioritizes safety.