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.

Medical Device Industry 98

Medical Device Industry Ransomware FDA Public Health 98

HIT Consultant

AUGUST 29, 2022

The medical device industry is booming and shows no signs of slowing down. In 2022, the FDA ( Federal Food and Drug Administration ) will clear or approve over 1,000 medical devices. Applicant: Valencia Technologies Corporation. Approval Date: March 1, 2022. Conclusion.

FDA 98

FDA Medical Device Industry Doctors Hospitals 98

Dot Compliance

SEPTEMBER 27, 2024

Regulatory Focus ISO 13485 is specifically aligned with the regulatory requirements of the medical device industry. It mandates detailed procedures for traceability, enabling the tracking of devices from raw materials to the end-user.

Medical Device Industry 59

Medical Device Industry Compliance Regulatory Compliance 59

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 97

Medical Device Industry FDA 97

McGuire Wood

JUNE 13, 2022

is a consultancy providing guidance and analytics to the pharmaceutical, biotechnology and medical device industries. Northlane Capital Partners has announced it has invested in SAI MedPartners. SAI , based in Reading, Pa., Founded in 1978, the company has offices across the Americas, Europe, India and Asia.

Medical Device Industry 52

Medical Device Industry 52

Healthcare IT Today

JULY 11, 2024

Our solutions power the efficient identification and management of Tuberculosis (TB), Lung Cancer, and Stroke to support clinicians and propel developments in the pharmaceutical and medical device industries. Originally announced June 25th, 2024

Medical Device Industry 78

Medical Device Industry FDA 78

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. This is where temporal artery technology comes in.

Medical Device Industry 98

Medical Device Industry Hospitals FDA World Health 98

HIT Consultant

MARCH 9, 2022

” Fahim added that the company is currently in negotiations with a number of imaging and medical device industry leaders to develop novel AR solutions. These innovative solutions will extend MediView’s leadership in the rapidly growing and evolving XR healthcare space.”

FDA 98

FDA Medical Device Industry COVID-19 98

Health Law Advisor

JANUARY 3, 2023

In keeping with the theme of these posts of unpacking averages, it’s important to drill down sufficiently to get a sense of the regulatory environment in which a particular company operates rather than rely on more global averages for the entire medical device industry. Conclusion.

FDA 98

FDA Medical Device Industry 98

Dot Compliance

JANUARY 30, 2024

Introduction: In the fast-evolving landscape of the medical device industry, ensuring the highest quality standards is paramount. Conclusion: The integration of AI into a QMS is reshaping how the medical device industry manages complaints.

Medical Device Industry 52

Medical Device Industry Compliance Regulatory Compliance 52

HIT Consultant

MAY 25, 2022

He brings to the company more than a decade of experience in the medical device industry. After serving as the primary caretaker for several family members following a cancer diagnosis, he started TailorMed with a personal mission to leverage technology to remove barriers to care.

COVID-19 Vaccine 98

COVID-19 Vaccine Medical Billing Medical Device Industry Pharmaceutical Industry 98

HIT Consultant

AUGUST 21, 2023

He brings more than a decade of experience in the medical device industry to the company. After serving as the primary caretaker for several family members following a cancer diagnosis, Srulik started TailorMed with a personal mission to leverage technology to tackle the financial challenges of care delivery.

Medical Device Industry 98

Medical Device Industry Patient Satisfaction Hospitals Governance 98

Healthcare IT Today

DECEMBER 29, 2022

With extensive healthcare and medical device industry knowledge, and decades of experience in investing and startup operations, Engage delivers a flexible and investor-friendly structure utilizing Special Purpose Vehicles (SPVs).

Due Diligence 69

Due Diligence Medical Device Industry FDA 69

McGuire Wood

JUNE 29, 2022

Ampersand Capital Partners has completed an investment in Sterling Medical Devices, according to a news release. is a provider of electromechanical and software solutions for the medical device industry. Sterling , based in Moonachie, N.J.,

Medical Device Industry 40

Medical Device Industry 40

HIT Consultant

MARCH 24, 2022

The lead-to-cash process in most B-to-B organizations––particularly those operating in the medical device industry––is often complex and lengthy. Chris Lekander, VP of Delivery, Wilco Source. This is even more apparent when operations, sales and customer success teams operate in manual and siloed environments.

Medical Device Industry 98

Medical Device Industry 98

Healthcare IT Today

APRIL 13, 2023

Virtonomy’s digital twin technology can help enhance medical device design in a virtual patient setting, accelerating development timelines and reducing costs, risk, and regulatory barriers. Virtonomy is reinventing how medical devices are safely and quickly brought to patients.”

Medical Device Industry 93

Medical Device Industry Governance 93

HIT Consultant

OCTOBER 10, 2022

As connected, wirelessly powered devices become smaller, lighter and more self-contained, it will open up new possibilities in the medical device industry and enable new standards of patient care. But one of the most exciting aspects of real wireless power is its capacity to drive innovation.

Medical Device Industry 98

Medical Device Industry COVID-19 Hospitals Public Health 98

Healthcare IT Today

FEBRUARY 15, 2024

Tim Bowe, CEO at Full Spectrum Within the healthcare and medical device industries (as well as virtually every other one), focus on incorporating AI into product suites has been a major focus. Responsible, evidence-backed AI solutions designed with physicians’ needs in mind will go a long way toward mitigating this challenge.

Medical Device Industry 130

Medical Device Industry Medicaid Medicaid Nurses 130

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

SEPTEMBER 13, 2024

The medical device industry balances innovation with patient safety. At the center of ensuring the reliability and effectiveness of these devices is ISO 13485, a globally recognized standard for quality management systems (QMS).

Medical Device Industry 52

Medical Device Industry Regulatory Compliance Compliance Patient Satisfaction 52

Exeed Regulatory Compliance

JULY 6, 2020

We will cover the other types of medical PPE in another video. Let us know your questions or comments and subscribe here to start receiving our exclusive, in-depth analysis of new developments in the medical device industry.

COVID-19 52

COVID-19 FDA Medical Device Industry Public Health 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

Exeed Regulatory Compliance

JULY 10, 2020

Plus, subscribe here to start receiving our exclusive, in-depth analysis of new developments in the medical device industry. If you have any questions or comments, don’t hesitate to get in touch. References FDA (2020, May).

COVID-19 52

COVID-19 FDA Medical Device Industry Public Health 52

HIT Consultant

JUNE 12, 2024

About Joe Wong Joe Wong is a seasoned leader in developing complex instrumentation, with extensive experience guiding teams through the product development framework, particularly in the medical device industry.

Medical Device Industry 45

Medical Device Industry Governance Compliance 45

Dot Compliance

SEPTEMBER 2, 2024

Navigating the complexities of ISO 13485 can be overwhelming for medical device manufacturers. This international standard sets the benchmark for quality management systems (QMS) in the medical device industry, ensuring product safety and efficacy.

Regulatory Compliance 52

Regulatory Compliance Compliance Medical Device Industry 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. Furthermore, the increased adoption of digital technologies for quality management is serving to boost process efficiency in a more cost-effective manner.

FDA 52

FDA Medical Device Industry COVID-19 Compliance 52

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

Exeed Regulatory Compliance

APRIL 2, 2020

Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. Medical device industry is changing fast! Technology is driving rapid innovation and medical devices are becoming more interconnected, and smart!

FDA 52

FDA Medical Device Industry Doctors Regulatory Compliance 52

HIT Consultant

OCTOBER 22, 2021

Helia Care —the first software company to capitalize on cloud-based technology to reimagine transaction processes between health systems and the medical device industry appoints Gregg Smith as Chief Commercial Officer.

Medical Device Industry 52

Medical Device Industry 52

SQA

SEPTEMBER 10, 2021

I have been working in manufacturing and the medical device industry for more than 20 years. In San Luis Obispo, I had the choice of only one company in the field of electronics, PTK (now Rantec), and I applied to it.

Nurses 88

Nurses Medical Device Industry FDA Hospitals 88

Hall Render

MARCH 1, 2023

Track – Physicians, advanced practice providers, and teaching hospitals should track all interactions with the pharmaceutical and medical device industry involving payments or transfers of value to ensure the accuracy of data reported in the Open Payments system on an annual basis.

Hospitals 40

Hospitals Payment Systems Nurses Medical Device Industry 40

Dot Compliance

JUNE 16, 2022

Accordingly, the International Organization for Standardization (ISO) and the American Food and Drug Administration (FDA) developed their own regulations governing quality management for medical devices. The ISO developed ISO 13485 , a stand-alone quality management standard (QMS) specific to the medical device industry.

FDA 52

FDA Regulatory Compliance Compliance Governance 52

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.” The court next addressed the defendant’s motion to exclude the plaintiff’s regulatory rebuttal expert as unqualified to offer the opinions in his report.

Medical Device Industry 59

Medical Device Industry Regulatory Compliance FDA Compliance 59