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Tag: medical device regulation

NHRA Guidance on Medical Devices Registration: Variations

The new article highlights the aspects related to changes to existing licenses and also addresses some other matters,...

eQMS: Streamlining ISO 13485 Compliance & Registration – Medical Device Regulation and ISO quality standard

Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting...

Asensus Surgical Provides Preliminary 2022 Year-End Corporate Update

RESEARCH TRIANGLE PARK, N.C., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the...

T-Heart Appoints Sarah Sorrel as Independent Board Member

PARIS–(BUSINESS WIRE)–T-Heart, a medtech company developing a truly novel and differentiated transcatheter tricuspid prosthetic heart valve specifically designed for tricuspid regurgitation, today announced it...

MDCG Guidance on Authorized Representatives: Responsibilities, Liability, and Termination

The new article describes in detail the aspects related to the responsibilities of authorized representatives as set forth...

Medical Devices and Their Environmental Impact

Climate change is a persistent and important issue globally. Many countries and companies are trying their best to implement policies that will combat the...

AI Device Clinical Evaluation Guideline and Seven Others to be Released Soon

The committee meeting of the China Artificial Intelligence Medical Device Innovation Cooperation Platform was held online on September 21, 2022. Focusing on bio-digital integration,...

Alexander Tokman Joins Izotropic Board of Directors

Vancouver, British Columbia--(Newsfile Corp. - November 11, 2022) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a dedicated breast...

TGA Guidance on Clinical Evidence for Supportive Devices

The new article describes in detail the aspects related to the clinical evidence required for meshes, patches, and tissue adhesives.  Table...

FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Study Procedures and Summary

The new article highlights the key points related to study procedures in pediatric clinical investigations, and also provides a summary of the key points...

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