Medical Equipment Compliance Obligation

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Quality and Compliance (Medical Devices) | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices

The FDA takes enforcement action to bring medical device manufacturers into compliance when manufacturers may not be complying with medical device laws. However, relying on enforcement...

Compliance Guidance | Office of Inspector General

https://oig.hhs.gov/compliance/compliance-guidance/

Compliance Guidance OIG has developed a series of voluntary compliance program guidance documents directed at various segments of the health care industry, such as …

Durable Medical Equipment Company Compliance: …

https://www.natlawreview.com/article/durable-medical-equipment-company-compliance-seven-tips

Compliance is the best safeguard against inadvertent mistakes and even instances of fraud and abuse within the company. DME companies can achieve DME …

Medical Device Compliance | Knowledge Center - Steris

https://www.steris.com/healthcare/knowledge-center/equipment-maintenance/medical-device-compliance

Secondly, Medical Equipment Compliance is important to be compliant with The Joint Commission standards. In 2017, The Joint Commission (TJC) mandated that 100% compliance is required for all …

Compliance with Medical Device Regulatory Changes

https://www2.deloitte.com/us/en/pages/advisory/articles/medical-technology-regulation-change-implications.html

Planning for compliance with regulatory changes New or updated medical device regulations—from the International Organization for Standardization (ISO), the European …

Medical Equipment Inspection Requirements - oshamanual.com

https://www.oshamanual.com/compliance101/article/medical-equipment-inspection-requirements

Equipment Inspection Checklist Medical facilities must have an equipment inspection checklist to perform quality checks and stay on track with compliance …

A Guide to Healthcare Compliance Regulations

https://www.michiganstateuniversityonline.com/resources/healthcare-management/a-guide-to-healthcare-compliance-regulations/

The law requires healthcare providers implement a compliance and ethics program as a condition for reimbursement for patients enrolled in federally funded healthcare programs. The ACA …

Hospital Equipment Maintenance Requirements | CMS

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-14-07

• Hospitals electing to adjust facility or medical equipment maintenance must develop policies and procedures and maintain documentation supporting their …

Durable Medical Equipment (DME) Company Compliance

https://federal-lawyer.com/healthcare-compliance/dme-company-compliance/

Like all service providers and suppliers that bill Medicare, Medicaid, Tricare, and the Department of Labor (DOL), durable medical equipment (DME) companies are subject …

4 Key Compliance Issues for Medical Device Companies

https://www.greenlight.guru/blog/4-key-compliance-issues-for-medical-device-companies

Every medical device company is required to follow a robust procedure for complaints as outlined in 21 CFR 820.198. A lack of or inadequate complaint procedures as per this section of the legislation …

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