Healthcare IT Today

APRIL 8, 2024

Clients of both companies can expect a seamless transition during the integration of the two companies and can continue to contact their current representatives for support needs. Widespread use of effective screening followed by appropriate interventions and monitoring will benefit hundreds of millions of patients worldwide.

FDA 89

FDA 89

Dot Compliance

OCTOBER 10, 2022

When the product itself cannot be examined, process validation guarantees that the procedures used to make the device comply with FDA rules. From 2011 to 2015, the top FDA warning letter citation for design controls was design validation. Contact Dot Compliance. Does the device operate in the user’s surroundings?

FDA 52

FDA Compliance 52

Dot Compliance

OCTOBER 10, 2022

When the product itself cannot be examined, process validation guarantees that the procedures used to make the device comply with FDA rules. From 2011 to 2015, the top FDA warning letter citation for design controls was design validation. Contact Dot Compliance. Does the device operate in the user’s surroundings?

FDA 52

FDA Compliance 52

Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases. -FDA

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

The Digital Health Corner

JUNE 14, 2017

According to most recent statistics from the Office of the National Coordinator, use of EHRs has increased from 20% in 2004 to 87% in 2015. I’d like to discuss what I believe are five areas of significant opportunity for quality technologies. EHRs were designed as documentation centers for billing and regulatory purposes.

Patient Satisfaction 87

Patient Satisfaction Hospitals FDA Governance 87

SQA

SEPTEMBER 2, 2022

Call for Companies to Register their Industry Single Point of Contact (i-SPOC) on Supply and Availability, 28 June 2022. All pharmaceutical companies with a centrally-or nationally-authorized medicinal product in the EU are required to register a single point of contact. ISPE Good Practice Guide: Critical Utilities GMP Compliance.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

Dot Compliance

DECEMBER 7, 2022

Ensuring Compliance with ISO 9001, EU MDR, FDA & More 6. A quality management system (QMS) is a codified system (paper or software-based) for documenting roles, processes, and procedures to develop goods that comply with FDA, ISO, EU MDR, and other regulatory standards as well as client expectations. The Bottom Line. QMS Timeline.

FDA 52

FDA Compliance Records Management 52