Life Sciences Software Development

Yes. We’ve built software in compliance with FDA regulations, IEC 62304 (medical device software lifecycle), 21 CFR Part 11 (electronic records and signatures), EU MDR (European medical device regulation), and CE marking (European conformity) requirements. We know the documentation, traceability, and validation these standards demand. SEP is also ISO 9001 (quality management system) certified, which reinforces the practices that regulated work requires.

Yes. We have experience developing software that functions as a medical device, including applications for patient monitoring and diagnostics. We build with the regulatory pathway in mind from the start, including risk management, design controls, and validation planning.

Security is built into how we work. Our IT and security leadership maintains the training, policies, processes, and infrastructure that keep every engagement secure. For life sciences projects, that foundation supports encrypted data at rest and in transit, secure authentication, role-based access controls, audit trails, and architecture designed to meet HIPAA requirements.

Yes. We’ve helped pharmaceutical companies standardize their development environments and implement DevOps practices that reduce setup timelines, lower costs, and improve supportability, all while maintaining the controls and documentation that regulated industries require. For one client, we reduced the environment setup time from 30 days to 30 minutes.

Absolutely! We start by understanding the existing system thoroughly, documenting current functionality, and identifying what has to be preserved for regulatory compliance. From there, we modernize in phases, validating each step to maintain compliance continuity. For medical devices, this includes managing the regulatory impact of every change.

You’ll work with a dedicated team that includes software engineers, designers, and a project lead — people who’ve built regulated software before and understand what’s at stake when it has to work. You bring deep knowledge of your product, your patients, and your compliance requirements. We bring the technical depth and process discipline to build it right. Together, we stay aligned through clear communication and a shared understanding of what the software actually has to do.