NioReg specializes in transforming medical device ideas into market-ready prototypes, backed by robust regulatory documentation and validation processes. Our sister company offers a suite of services designed to navigate the complex landscape of medical device development and regulatory compliance, ensuring your product meets the highest standards of safety, efficacy, and quality.
Key Services Offered by NioReg:
- Design Project Plan: A detailed roadmap that guides the transformation from concept to prototype, including design verification, validation, and transfer, complemented by necessary regulatory documentation.
- Design Infrastructure Service: Expert evaluation of design plans to facilitate prototype development, with proposals for engineering changes and setup of required equipment and infrastructure.
- Process Validation: Comprehensive validation services, from design to production, ensuring processes reliably produce high-quality products. Services include packaging, cleaning, sterilization, and production validation.
- Usability Engineering and Human Factor Design: Development of usability protocols according to EN/IEC 62366-1 standard, ensuring comprehensive usability testing and reporting.
- Design File Preparation: Assistance in preparing design files to meet regulatory requirements for market release, including documentation development and customer collaboration.
- Transport Simulation Tests (ASTM D4169): Evaluation of product resistance to distribution environments, with a complete protocol for environmental conditioning, vibration, drop, compression, vacuum, and concentrated impact testing.
- Laboratory Services: Offering stability analysis, packaging integrity tests, and transport simulation tests, ensuring products meet required standards for sterility, shelf life, and distribution resilience.
NioReg's approach is tailored to each client's specific needs, ensuring not only compliance with regulatory standards but also the successful introduction of innovative medical devices into the market. For more detailed information on NioReg's services and to request a quote, please visit our website or contact us directly at info@nioreg.com.
