Peter Brady Email & Phone Number

I'm something of a rare combination. I'm an experienced software developer, well versed in modern software engineering practices, like agile methodologies, in computer science subjects, such as computer vision and artificial neural networks and also in safety critical systems and software development. Unusually for someone with this background, I'm also an ISO 13485 lead auditor and consult with a notified body as technical specialist in medical device software, SaMD and AI/ML development. This includes the practical application of regulation and standards - such as ISO 13485 and its application to software and AI, IEC 82304 and IEC 62304, ISO 14971 and IEC 62366 - and also the many guidance notes from the EU and the US on subjects such as qualification and classification, cybersecurity and clinical evidence.My mission is to guide innovative medtech businesses through the the complex world of medical device regulations and standards, enabling them to create successful products, reduce development costs and accelerate time to market.I believe technology has a huge role to play in the continued improvement of healthcare - to cure disease, relieve suffering and to save lives. I want to make sure that regulation never holds back innovation.Let’s be clear, regulation is there for a reason. Medical technologies should be demonstrably safe and effective. This additional burden of proof can be considered too onerous by some, however, with the right guidance, regulatory approvals are not only achievable but are a significant competitive advantage.I have a 100% successful track record of guiding my clients to certification for ISO 13485, ISO 27001, and ISO 14001. I have a 100% track record in helping clients place their devices on the market in the UK, EU, US, and other territories. I'm the founder of Daedalus Compliance - a highly cost effective eQMS and compliance system for ISO 13485, MDR, IVDR, FDA QSR and MDSAP regulatory requirements. Daedalus Compliance also includes processes for Risk Management (ISO 14971), Health Software (IEC 82304), Software Development (IEC 62304) and Usability Engineering (IEC 62366). The system also includes many templates to help speed time to market and reduce development costs.

Listed skills include Medical Devices, Product Development, R&D, Iso 13485, and 43 others.