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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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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- Apr 23
- 2 min
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
- 2 min
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
- 2 min
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
- 4 min
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
- 2 min
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
- 3 min
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
- 5 min
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
- 2 min
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
- 3 min
Remote Patient Monitoring (RPM)
Remote Patient Monitoring (RPM) allows healthcare providers to monitor patients outside of conventional clinical settings
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