Dot Compliance

JANUARY 30, 2024

Introduction: In the fast-evolving landscape of the medical device industry, ensuring the highest quality standards is paramount. This proactive approach helps medical device companies minimize the likelihood of recurrent issues, ensuring compliance with regulatory standards and safeguarding patient safety.

Medical Device Industry 52

Medical Device Industry Compliance Regulatory Compliance 52

Dot Compliance

MARCH 7, 2024

Digital transformation has ignited a change in the medical device industry, one that leverages technology to create life-saving devices. Not just as a component of a medical device but as the medical device itself. This clear distinction is what’s known as Software as a Medical Device (SaMD).

Medical Device Industry 52

Medical Device Industry Compliance 52

Dot Compliance

JUNE 16, 2022

Maintaining compliance with safety and quality standards is a significant issue in medical device manufacturing. Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. The QMS supports the manufacturers, leading to ISO confirmation and FDA compliance.

FDA 52

FDA Regulatory Compliance Compliance Governance 52

Healthcare IT Today

FEBRUARY 15, 2024

To mitigate this, continuous investment in cybersecurity measures and adding modern security and compliance protocols is essential. If unaddressed, this could lead to significant data breaches, undermining the integrity of AI systems in healthcare, like those used in modern EHRs and medical coding.

Medical Device Industry 112

Medical Device Industry Medicaid Medicaid Nurses 112

HIT Consultant

OCTOBER 10, 2022

In addition to applications that enable more rapid scaling of hospital capacity and the deployment of more devices to generate better data, healthcare applications include wirelessly powered medical devices that don’t limit patient mobility within a hospital room or at home, which can result in better compliance rates.

Medical Device Industry 98

Medical Device Industry COVID-19 Hospitals Public Health 98

Healthcare Law Blog

APRIL 13, 2022

On March 18, 2022, AdvaMed announced updates to the Code of Ethics on Interactions with Health Care Professionals (“Code”), a voluntary code that provides medical technology companies with guidance on ethically compliant interactions and relationships with healthcare professionals. The changes will take effect on June 30, 2022.

Fraud 52

Fraud Medical Device Industry Compliance COVID-19 52

Dot Compliance

FEBRUARY 3, 2022

Let’s look at what’s on the horizon for the medical device industry in 2022 and how manufacturers can achieve multiple goals by digitizing their quality operations. Best Practices for Medical Devices, AAMI, September 29, 2021 2 New draft guidance to support risk-based computer software assurance,ISPE Boston, November 7, 2019.

FDA 52

FDA Medical Device Industry COVID-19 Compliance 52