HIT Consultant

FEBRUARY 8, 2024

AI-Powered Clinical Trials with Digital Twins Founded in 2017, Unlearn has consistently pushed the boundaries of AI in clinical research. Regulatory Backing for Innovation Unlearn understands the importance of regulatory compliance. founder and CEO of Unlearn.

Regulatory Compliance 97

Regulatory Compliance FDA Health Outcomes Compliance 97

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. One challenge confronting the industry is that the regulatory pathway for these inter-connected devices is far from clear.

FDA 52

FDA Medical Device Industry Doctors Regulatory Compliance 52

Exeed Regulatory Compliance

FEBRUARY 25, 2020

According to a 2018 report from Deloitte , the IoMT market is expected to grow from $41 billion in 2017 to $158 billion by 2022. Regulatory Breakthrough In a small step towards achieving the vision of interoperable medical devices, the FDA has recently authorized marketing of a novel software medical device using the De Novo Classification.

FDA 52

FDA 52

Dot Compliance

JANUARY 14, 2022

There are many risk management regulations and compliance standards in the life sciences industry that must be followed to successfully maintain business operations and ensure the safety of staff and product users. EU MDR 2017/745. FDA’s Safer Technologies Program (SteP) for Medical Devices. Source: [link]. Source: [link].

Compliance 52

Compliance FDA Regulatory Compliance Governance 52

Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

Bill of Health

APRIL 4, 2024

Beyond the health care sector-specific Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), this mix of AI & Data related regulatory requirements stems from a series of generalized, cross-sectoral EU laws of the last 5 years.

FDA 282

FDA Regulatory Compliance Malpractice Health Insurance 282

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105