Quality credentials RTEmd holds ISO 13485 and ISO 9001 certifications and 62304 compliance, with extensive clinical and FDA experience, signaling a strong quality foundation that reduces regulatory risk for clients and supports faster time-to-market.

On-time delivery With over 95% of medical device projects completed on-time and within budget, RTEmd can be positioned as a reliable partner to de-risk schedules, enabling clients to meet launch timelines and regulatory milestones.

Repeat engagements More than 90% of customers return for additional outsourcing services such as new product development, sustaining engineering, SQA, and regulatory support, indicating strong customer satisfaction and potential for expand-with-current-client opportunities.

Regulated software focus Specialization in compliant embedded software, real-time control, connectivity, data management and mobile medical apps aligns with needs in IVD, imaging, patient monitoring, infusion pumps and other regulated devices.

Small team, outsized impact A compact team with deep regulatory and clinical experience offers an agile, cost-competitive option for mid-market medical device firms seeking specialized software development, sustaining engineering, and quality/regulatory support.