QMSR will align FDA's medical device quality management system with ISO 13485:2016. It will be released by the end of this year and become effective one year later. This harmonization is expected to save medical device companies at least $439 million over the next decade.

• The global blood pressure monitoring devices market is set to grow by 9.4% CAGR from 2023 to 2030.
• Homecare to show fastest CAGR of ~11.3% due to smart wearables mobility.
• North America held the largest revenue share in 2022, and Asia-Pacific is expected to expand fastest over the forecast period.