Medicaldevices.freyrsolutions.com

What is the PreSTAR Program

WebThe United States Food and Drug Administration (U S F D A) has introduced the PreSTAR (for early submission requests), which is an extension of the eSTAR program, as a beta …

Actived: 5 days ago

URL: https://medicaldevices.freyrsolutions.com/what-is-article/what-is-the-prestar-program

Health Canada Medical Device Registration

WebFreyr provides Health Canada medical device registration and approval support for device manufacturers that includes registration, classification and Medical Device Establishment …

Category: Medical Go Health

Medical Device Regulatory Intelligence

WebThe Medical Device Regulatory Intelligence is a multi-dimensional activity and includes monitoring of Regulatory environment, Procedural and competitor intelligence. The …

Category: Medical Go Health

Medical device Regulatory Consulting, IVD Regulatory Consulting

WebAs a medical device consulting and IVD Regulatory consulting organization, Freyr is uniquely positioned to deploy best vertical/divisional in-house experts to provide the best …

Category: Medical Go Health

Registration Requirements for Medical Devices in GCC Countries

WebMedical device manufacturers must complete the Gulf Cooperation Council (GCC) medical device registration process to sell their products in Bahrain, Kuwait, …

Category: Medical Go Health

Mexico Medical Device Registration, Mexico Registration Holder …

WebMexico Medical Device Registration Overview. Mexico is the import hub for Medical Devices in Latin America. Mexico Medical Device Registration is regulated by the Federal …

Category: Medical Go Health

Upcoming Changes in Brazil’s Medical Device Labeling and …

WebThe Brazilian Health Regulatory Agency, ANVISA, issued Resolution RDC 751, which recently specified the standards and guidelines for the notification, …

Category: Health Go Health

Medical Device Registration in Indonesia

WebMedical Device Registration in Indonesia, Indonesia Local Authorised Representative. Book a Meeting. +1 908 483 7958. [email protected].

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Resolution for Regulation of Software as Medical Device (SaMD) in

WebThe National Health Surveillance Agency of Brazil (ANVISA) published a resolution RDC no. 657 on March 30, 2022, regulating Software as a Medical Device (SaMD). The resolution …

Category: Medical Go Health

HSA Medical Device Registration, Classification, Singapore

WebFreyr provides End-to-end medical device regulatory services in Singapore that span across product registration, classification, Authorized representation services, label support, …

Category: Medical Go Health

Throwback 2021 – Life Sciences Industry Outlook

WebIt is apparent that COVID-19 has permanently changed the ways of business operations for many industries across the globe. In fact, it has subtly given a renewed purpose to …

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Decrypting Data Privacy in the Healthcare Sector

WebAs a customer of Freyr Software Services Pvt. Ltd, we would like to express our appreciation for the high-quality and efficient work performed by your team in …

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Vietnam Medical Device Registration

WebVietnam Medical Device Registration, Vietnam Local Authorized Representative. Book a Meeting. +1 908 483 7958. [email protected].

Category: Medical Go Health

Ensuring Product Safety: Post-market Surveillance (PMS) in Australia

WebJune 19, 2023. The core objective of post-market monitoring and vigilance is to enhance the well-being and safety of patients, healthcare professionals, users, and others by …

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