Are you responsible for bringing a new electronic medical device to market? Does your company have mechanical and electrical design covered, but you need help with the embedded software that powers your device?You might be wondering:► Am I sure my device software is compliant with relevant standards such as IEC 62304, ISO 14971, and ISO 60601-1?► Am I sure I won't need yet another board re-spin due to missing functionality that we won't discover until we are ready for V&V?► If I engage with a larger firm, will my project be passed off to junior, less-experienced engineers or an off-shore development team?Wouldn't it be great if you could be confident that your 510(k) or PMA submission would succeed without being rejected for poor software development processes or documentation? That's where I come in. I've been developing real-time, safety-critical embedded software and firmware for 18 years, and I've focused exclusively on the medical device industry for the past 10 years. I've led software development efforts in all stages, from early requirements gathering to V&V and regulatory documentation. I can help in one of three ways:► Custom Development and Documentation — Deliver a complete embedded software and documentation package, ready to be included in your Design History File and regulatory submission► IEC 62304 and Regulatory Compliance — Help your software team understand and create the processes and documents they need to get through FDA, with minimum overhead► Expert Software Guidance — advisory calls or engagements to answer any questions you may have about processes, architecture, or medical device softwareIf you'd like to see if we'd be a good fit to work together, message me here on LinkedIn, or send me an email at jeff@jeffgable.com.