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.
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…
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.
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…
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…
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…
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…
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…
Breaking into healthcare is hard. Breaking into MedTech is harder — thanks to complex regulations, long sales cycles, and conservative procurement paths. For early-stage medtech startups, choosing the right go-to-market (GTM) strategy can be the difference between scaling and stalling. This guide breaks down the GTM playbook for MedTech in 2025, with a focus on…
With over €20 billion in public and private capital flowing into digital health ventures since 2020, the European Union has become a strategic launchpad for healthtech founders. But where exactly does this capital come from? And what’s the smartest path for early-stage startups looking to digital health funding? This in-depth guide breaks down the EU…