ISO 10993-1 | What’s new in the latest draft standard?
ISO 10993-1 provides the governing foundation for the biological evaluation of medical devices, explaining the fundamental requirements and general principles.…
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Post-market clinical follow-up under the EU MDR
Post-market clinical follow-up (PMCF) has become significantly more rigorous under the EU MDR to ensure enhanced patient safety following a…
Congenius
How to integrate an ISMS into your existing QMS
In the MedTech industry, information security is not just an IT issue – it’s fundamental to patient safety. MedTech companies…
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Medical device reimbursement | 5-minute guide
Medical device reimbursement refers to the process by which manufacturers, healthcare providers, and patients obtain financial coverage for medical devices…
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Navigating the regulatory landscape of fast-growing markets | South Africa
The growth of South Africa’s medical device market has been largely driven by increased healthcare demand due to an aging…
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Navigating the regulatory landscape of fast-growing markets | India
India has one of the world’s largest consumer markets. With a large and growing population, rising prevalence of chronic diseases,…
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Navigating the regulatory landscape of fast-growing markets | Mexico
Mexico’s population is 126 million – and counting. As healthcare becomes increasingly affordable and accessible to the country’s growing population,…
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Navigating the regulatory landscape of fast-growing markets | Brazil
Brazil stands as a cornerstone of the Latin American healthcare market, but healthcare needs amongst its sizable population are evolving…
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