Medicaldevices.freyrsolutions.com

Non-conformance Management in Medical Devices

WEBMedical devices play a vital role in improving patient health, but non-conformities in the devices can occur even with the best quality control systems in place. …

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URL: https://medicaldevices.freyrsolutions.com/blog/non-conformance-management-in-medical-devices

Health Canada’s Inspection Process for Licensed Medical Device

WEBA Medical Device Establishment Licence (MDEL) is a license issued to Class I medical device manufacturers, importers, or distributors of all device classes. In a recent …

Category: Medical Go Health

Health Canada Releases Notice on Research Use Only COVID-19 …

WEBHealth Canada has clarified its stand on the research use only testing kits related to COVID-19. Health Canada regulates the import and sale of medical devices and IVDs …

Category: Medical Go Health

What are MDL and MDEL

WEBMedical Device Licence (MDL) and Medical Device Establishment Licence (MDEL) are the licenses issued by Health Canada, the Health Agency regulating the medical devices …

Category: Medical Go Health

COFEPRIS’ New Requirements for Online Submission of Medical …

WEBIn April 2022, COFEPRIS announced new rules for medical device submission. Until 2021, every application was printed, gathered, and submitted in …

Category: Medical Go Health

Strategies for Navigating the Compliance Maze of Digital Health

WEBAs digital health startups continue to disrupt traditional healthcare practices, businesses must be compliant with regulations to ensure sustainable success. However, …

Category: Health Go Health

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 …

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 …

Category: Medical Go Health

Ensuring Device Safety: PMS in Brazil Freyr Medical Devices

WEBJune 28, 2023. Post-market surveillance (PMS) is a system through which surveillance of adverse events and malfunctions of health products in the post-market phase are …

Category: Health 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 …

Category: Health Go Health

Medical Device Registration in UAE, UAE Local Authorized …

WEBMedical Device Registration in UAE Overview. United Arab Emirates (UAE), a prominent GCC member Nation, has an advanced healthcare system. Its market potential is …

Category: Medical Go Health

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 …

Category: Health 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 …

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

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 …

Category: Health Go Health