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Importance of Regulatory Compliance in Healthcare

Compliancy Group

Regulatory compliance in healthcare ensures quality care for patients. In this blog, we’ll outline the fundamentals and importance of regulatory compliance in healthcare in the U.S. What Does Regulatory Compliance in Healthcare Involve? Regulations also mandate the proper use, storage, and disposal of PPE.

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The Ultimate Guide to ISO 9001

Dot Compliance

Prior to ISO 9001:2015, the standard for Quality Management Systems (QMS) was ISO 9001:2005. Organization for International Standardization (ISO): ISO is a global organization that creates standards for a variety of sectors, including the pharmaceutical industry. The procedure of inspection and certification is not handled by the ISO.

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How the Medical Industry Can Help Combat the Current Coronavirus Crisis

Exeed Regulatory Compliance

A 2005 report HHS Pandemic Influenza Plan last updated in 2017, estimates that 25 – 35% of the population could be infected during a pandemic and recommends stockpiling adequate supplies for at least 6-8 weeks. Healthcare workers in hospitals, outpatient clinics and emergency response teams are at high risk.

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FDA Finalizes Its Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors

Hall Render

These entities share responsibility of regulatory compliance as it relates to the form and process for informed consent.

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Federal Officer Removal Fails In California

Drug & Device Law

308 (2005), which comes up not infrequently in drug and device product liability cases. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do. Darue Eng’g & Mfg. ,