About NR Sign Inc.

About NRSign

At NRSign, we are committed to advancing healthcare innovation through the design, development, and manufacturing of cutting-edge investigational and research medical devices. As a trusted partner in the medical device industry, we combine technical expertise with regulatory proficiency to bring pioneering solutions to life while ensuring compliance with global standards.

Our Approach

Our integrated approach covers every stage of product development, from initial concept and prototyping to clinical validation and regulatory approvals. By specializing in both the engineering and regulatory aspects of investigational devices, we provide a seamless pathway for bringing innovative technologies to market.

With extensive experience in navigating complex regulatory landscapes, including Investigational Device Exemption (IDE) applications and approvals from major health authorities such as the FDA and EMA, we ensure that each device meets the highest standards of safety, efficacy, and compliance.

Our Services

✅ Design, development, and manufacturing of investigational and research medical devices
✅ Regulatory strategy and pathway consultation
✅ Preparation and submission of regulatory applications (e.g., IDE, 510(k), PMA, ITA, Health Canada Approvals)
✅ Clinical trial design and support for investigational devices
✅ Quality management systems and ISO certification readiness
✅ Post-market surveillance and compliance support

At NRSign, we are passionate about transforming innovative ideas into tangible medical advancements. Our multidisciplinary team of engineers, quality assurance experts, and regulatory specialists ensures that your devices are not only effective but also compliant with stringent industry standards.

Empowering healthcare pioneers worldwide, we deliver solutions that improve lives while accelerating the journey from research to reality.