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Global Insights - Devices & IVDs
Access insights from our industry experts on everything from country-specific regulations, case studies, facts to the latest advancements in the MedTech industry.
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Jun 24, 20244 min read
User Interfaces of Unknown Provenance (UOUP) in Medical Devices
User Interfaces of Unknown Provenance (UOUP) in medical devices refers to situations where the usability aspects of a device are not...
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Jun 2, 20245 min read
Importing Medical Device Samples into India: CDSCO Regulations and Necessary Approvals
The importation of medical device samples into India plays a crucial role in ensuring that these devices meet the stringent standards...
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May 25, 20243 min read
ISO 62366 : Usability Engineering File (UEF) for Medical Devices
The Usability Engineering File (UEF) is a comprehensive collection of documents that demonstrate a medical device's compliance with the...
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May 24, 20244 min read
ISO 62366 Human Factor Usability Engineering : A Guide for Medical Device Manufacturers
Usability engineering is an essential aspect of medical device design, ensuring that devices are effective, safe, and user-friendly. ISO...
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May 23, 20245 min read
Understanding ISO 20417:2021 for Medical Devices — Information to be Supplied by the Manufacturer
ISO 20417:2021 is a pivotal standard in the medical device industry, focusing on the comprehensive information that manufacturers must...
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May 23, 20242 min read
Finding the Right Medical Devices Distributors in India
Artixio simplifies the process of identifying the most suitable distributors for your medical device in the Indian market
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May 20, 20244 min read
Medical Device Labeling : Understanding ISO 15223 Standard
In the world of medical devices, clear communication is paramount. This is where ISO 15223 standard steps in, providing a standardized...
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May 5, 20243 min read
Scientific Validity Reports (SVR) for IVDs under EU Regulation 2017/746 (EU IVDR)
With the advent of EU Regulation 2017/746 (commonly known as the EU IVDR), the introduction of Scientific Validity Reports (SVR) has...
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Apr 23, 20242 min read
Toolkit for Medical Device Registration by Startups
Here is a high level summary of how startups can plan their product development and commercialization for new medtech innovations/ideas.
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Apr 23, 20242 min read
Navigating the India Market: Finding a Medical Devices Distributor
Expanding your medical device business into India requires strategic planning and reliable local partners.
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Apr 22, 20242 min read
India’s Thriving Medical Devices Market: Opportunities and Challenges
By 2025, the Indian medical devices market is expected to reach approximately $50 billion
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Mar 22, 20244 min read
COFEPRIS Makes Changes to Revamp Medical Device Regulations
Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) introduced new guidelines for medical device registration
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Mar 12, 20242 min read
Key Considerations for Medical Device Branding in a Regulated Industry
Creating a strong brand for a medical device is crucial in today’s competitive market. Key considerations for branding a medical device.
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Feb 27, 20243 min read
Best Practices and Guidelines of compiling an effective Summary Of Safety And Clinical Performance (SSCP) for Medical Devices under EU MDR 2017/745
In the intricate landscape of medical device regulation, ensuring the safety and effectiveness of devices is paramount. Among the...
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Feb 20, 20245 min read
Summary Of Safety And Clinical Performance (SSCP) for Medical Devices under European Union Medical Device Regulation (EU MDR 2017/745)
The European Union Medical Device Regulation (EU MDR 2017/745) represents a significant update to the regulatory framework governing...
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Feb 7, 20242 min read
Case Study: Artixio’s Successful Registration of Dental Implants in Mexico (COFEPRIS)
Case study explaining Artixio’s Successful Registration of Dental Implants in Mexico
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Jan 17, 20243 min read
Remote Patient Monitoring (RPM)
Remote Patient Monitoring (RPM) allows healthcare providers to monitor patients outside of conventional clinical settings
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