AI in Medical Devices: Post-Market Surveillance and FDA Guidance
Artificial intelligence (AI) is transforming medical technology. Yet, unlike static hardware or conventional software, AI- medical devices (AIMD) evolve. Their algorithms can drift, degrade, or even introduce new risks once deployed in real-world clinical environments. For founders and product leads, this presents a challenge: how do you maintain regulatory compliance while allowing your AI model […]
IEC 62304 Compliance Checklist for Medical Device Software Teams
As medical devices become more software driven, it’s crucial that we get the safety and reliability right. That’s where IEC 62304 comes into play. In this blog, I’ll break down what IEC 62304 actually is, why it matters for anyone developing medical device software, and who should be paying attention. I’ve also pulled together a […]
How to Build a Regulatory Strategy for Medical Devices in 2025
Knowing the regulation is only half the battle. Understanding how to apply those regulations to your devices in a smart and innovative way, whilst ensuring compliance, can make all the difference. A good regulatory strategy doesn’t just focus on compliance, but it also develops the base for the design and development through to commercialisation and […]
How to Structure a Medical Device Technical File for EU MDR/IVDR
Technical file (TF) documentation is a structured compilation of documents demonstrating the device meets the regulatory requirements of the EU MDR 2017/745 and EU IVDR 2017/746. The TF must be compiled to meet the requirements of the EU MDR or EU IVDR, and be retained for the device lifetime: at least 10 years after the […]
Risk Management for MDR and IVDR Compliance in 2025
Understand how ISO 14971-based risk management supports MDR and IVDR compliance, from design to post-market surveillance.
FDA QSR vs ISO 13485: The Crucial Differences You Must Know
Navigating the regulatory landscape for medical devices can be complex, especially when comparing US requirements with other international standards. A common question is: