Clinical Evidence for SaMD in the EU
MDR Requirements SaMD must show: Documentation: Use real-world evidence, literature, or clinical studies. This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.
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The CE Marking Process for SaMD
Get CE Mark Most SaMD is Class IIa or higher—requiring Notified Body involvement. Key Steps: Class-specific routes: This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.
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SaMD Cybersecurity and GDPR
Security = Safety Under EU MDR, cybersecurity is a General Safety and Performance Requirement. Failure to secure software is a patient safety risk. Technical Steps: GDPR Considerations: This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.
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Building a Compliant QMS for SaMD
To enter the EU market, your SaMD must be developed under a Quality Management System (QMS) that complies with ISO 13485. What You Need Best Practices Cybersecurity Integration Use MDCG 2019-16 as a guideline for secure development. Cybersecurity is considered a safety issue under EU MDR, it is not just IT hygiene. Learn More: This…
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Rule 11 Explained: Classifying SaMD in the EU
EU MDR’s Annex VIII, Rule 11 determines how software is classified: What Determines the Class? Example: References: This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.
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What Is Software as a Medical Device (SaMD)?
Software as a Medical Device (SaMD) refers to software intended for medical purposes that performs these functions without being part of a hardware medical device. Under the EU MDR (Regulation 2017/745), it’s officially termed Medical Device Software (MDSW). Key Definitions MDSW under EU MDR aligns closely with the global SaMD concept defined by IMDRF. A…
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Mistakes to Avoid in MedTech Commercialization (and How to Fix Them)
Even with the right product, market, and team — many MedTech startups fail. And the reasons often come down to avoidable commercialization mistakes: misjudging the buyer, skipping regulatory nuance, or assuming your tech will sell itself. This final post in the Scaling MedTech: From Product to Market series lays out the most common missteps in…
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Commercial Channels That Actually Work in MedTech
For MedTech startups, success hinges not only on product quality, but also on how you reach, convince, and support stakeholders. Whether selling to hospitals, doctors, or patients, early-stage companies must design a channel strategy that reflects the healthcare buying process — slow, risk-averse, and influence-driven. This post breaks down the most effective commercial channels in…
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Cracking Reimbursement — Value-Based Pricing for MedTech Startups
Pricing in MedTech isn’t just a number — it’s your business model. In the EU, where public payers dominate and health systems are increasingly value-driven, getting paid requires clinical validation, health economic proof, and a clear story about long-term cost savings. This post breaks down how to approach reimbursement and pricing for MedTech startups, with…
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Market Access in Europe — What Founders Need to Know
Getting into the hospital is no longer the endgame. For MedTech startups in Europe, getting reimbursed — and doing so consistently across fragmented markets — is what separates hobby projects from scalable businesses. In this second post of our series, we dive into the European market access landscape for medical devices and digital health, with…