HIPAA Journal

APRIL 5, 2022

Over the course of the pandemic, cyberattacks on healthcare organizations have increased, and medical devices and the networks to which they connect have been affected by ransomware attacks. These attacks have affected hospitals, patients, and the medical device industry. Senators Bill Cassidy, M.D. (R-LA)

Medical Device Industry 125

Medical Device Industry Ransomware FDA HIPAA 125

HIT Consultant

MARCH 9, 2022

. – The XR50 , to be submitted for FDA clearance in the first half of the year, adds procedural guidance capabilities to the XR30 by creating a visible pathway for the practitioner’s instrument during procedures.

FDA 98

FDA Medical Device Industry COVID-19 98

HIT Consultant

NOVEMBER 17, 2024

The FDA has recognized the limitations of these devices noting that factors such as measurement location, distance of the sensor, individual physiological attributes and environmental conditions can all impact the reliable performance of NCITs.

Medical Device Industry 53

Medical Device Industry Hospitals FDA World Health 53

HIT Consultant

MARCH 28, 2024

Move from Innovation to FDA Submission in Just 90 Days The typical timeframe for engineering teams to move their orthopedic device innovations from market assessment and prototyping to documentation and submission is 12 months to two years. The industry-accepted average is 20 months.

Medical Device Industry 91

Medical Device Industry FDA 91

Dot Compliance

FEBRUARY 3, 2022

Many of the steps device manufacturers are taking today to improve quality management and supply chain resiliency are aligned with the U.S. Food and Drug Administration’s (FDA) goals for the industry. This issue of validation has also been raised by the FDA in relation to the adoption of AI and ML by device manufacturers.

FDA 52

FDA Medical Device Industry COVID-19 Compliance 52

Healthcare IT Today

DECEMBER 29, 2022

Engage Partner, Morgan Evans, will join VOCxi’s board of directors, bringing her industry expertise to support the investment. Evans, a medtech founder and executive, brings extensive experience in regulatory pathways, FDA clearance, and commercialization.

Due Diligence 61

Due Diligence Medical Device Industry FDA 61

Dot Compliance

JUNE 16, 2022

Government regulators have been doing their best to ensure that patients receive the safest and most efficient device possible. The two most relevant quality regulations for medical device manufacturers are the FDA 21 CFR Part 820 and the ISO 13485:2016. The FDA 21 CFR Part 820 is similar to the ISO 13485:2016.

FDA 52

FDA Regulatory Compliance Compliance Governance 52

Health Populi

FEBRUARY 21, 2023

The Morning Consult poll gives us some insights into this, nearly ten years later, through the observation of Scott Whitaker, chief executive of the medical device industry group AdvaMed, who is quoted in the study press release.

Medical Device Industry 62

Medical Device Industry Medicare Medicare FDA 62

SQA

SEPTEMBER 10, 2021

SoCal Parenteral Drug Association (PDA) Chapter 10th Annual Industry Summit (Vendor Night) , August 24 at The Grande event center in Long Beach, CA [link]. PDA/FDA Joint Regulatory Conference, The Roaring 20s: Crisis, Collaboration, Commitment to Quality, September 27-29 [link]. Advances, Adoption and Advocacy [link].

Nurses 88

Nurses Medical Device Industry FDA Hospitals 88

SQA

MAY 24, 2021

SQA has been partnering with Rx-360 in support of its members and sponsors to service the impact of local regulations in the life sciences and medical device industries, with the goal of achieving consistent supply chain standards worldwide. SQA was proud to support the past two days of the Rx-360 Euro 2021 Summit.

COVID-19 52

COVID-19 COVID-19 Vaccine Medical Device Industry FDA 52

Drug & Device Law

SEPTEMBER 2, 2022

The defendant argued that the expert “ha[d] no experience in regulatory compliance for the medical device industry, and any remotely relevant experience he had ended in 1989.”

Medical Device Industry 59

Medical Device Industry Regulatory Compliance FDA Compliance 59