Exeed Regulatory Compliance

JULY 10, 2020

The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. We recently discussed the FDA’s policy for Face Masks during COVID-19. So, there are two parts to the definition of these devices – what they are and how they are used.

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Exeed Regulatory Compliance

APRIL 2, 2020

Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. A new FDA guidance offers helpful recommendations for design and premarket submission. Medical device industry is changing fast! You can think of many other examples in your daily life.

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FDA Medical Device Industry Doctors Regulatory Compliance 52

Healthcare IT Today

JULY 11, 2024

Initial real-world studies and recent FDA clearances have provided compelling evidence for the potential of Qure.ai ’s medical imaging AI innovations,” said David M. Globally Qure.ai has delivered AI-augmented detection for Tuberculosis (TB), Lung Cancer and Stroke at over 2700 imaging sites, across more than 90 countries.

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Medical Device Industry FDA 78

HIT Consultant

JANUARY 31, 2024

What You Should Know: – ECRI , an independent healthcare safety organization, has released its annual Top 10 Health Technology Hazards list for 2024 , highlighting critical safety concerns for healthcare providers and the medical device industry. With each advance in technology, cybercriminals sharpen their tools.

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Medical Device Industry Ransomware FDA Public Health 98

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.

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Dot Compliance

JANUARY 7, 2025

Enhance compliance: Ensure compliance with FDA regulations, including CGMP and 21 CFR Part 11 , through automated compliance checks and audit trails. Scenario 3: Medical Device Manufacturer Improves Patient Safety Now well look at the medical device industry.

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Medical Device Industry Regulatory Compliance Compliance FDA 59

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.

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Due Diligence Medical Device Industry FDA 69

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.

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FDA Medical Device Industry COVID-19 Compliance 52

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.

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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.

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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].

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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.

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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.”

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