At EPINTEK, we are dedicated to providing comprehensive, one-stop Contract Research Organization (CRO) solutions that support medical device and IVD manufacturers throughout the entire product development lifecycle. With expert teams in regulatory affairs, quality systems, and laboratory testing, we work hand-in-hand to ensure your products meet the rigorous compliance requirements of major global markets — including China’s NMPA, EU MDR / IVDR, and US FDA 510(k) — so you can bring your innovations to market faster and with full confidence.

Our technical consulting services are structured to guide your product from concept through to commercialization:

Early Product Development Phase

· Conduct clinical scenario research and translate clinical needs into engineering requirements

· Identify applicable regulatory standards and compliance pathways

· Perform preliminary risk analysis and establish safety and performance benchmarks

· Define usability and sterile packaging design requirements

· Assess biocompatibility and material selection strategies

Product Design & Process Verification

· Develop and validate specialized manufacturing processes

· Optimize cleaning, packaging, and sterilization protocols

· Implement EMC (Electromagnetic Compatibility) design improvements

· Conduct formative usability evaluations and design optimization

· Establish risk control measures and implement quality-by-design principles

Design Validation & Market Access Support

· Perform packaging integrity and software validation

· Conduct pre-clinical animal studies and usability summative evaluations

· Execute clinical trials and clinical evaluations

· Provide local regulatory registration services as an official Authorized Representative for NMPA Registration, CE Certification, and FDA Registration.

By integrating our regulatory expertise with our advanced testing and R&D capabilities, EPINTEK ensures that your product not only meets current global standards but is also positioned for successful commercialization. Whether you're preparing for a 510(k) submission, CE marking under MDR/IVDR, or NMPA registration in China, our team is here to support you every step of the way.

For more information about our services or to tailor specific solutions, please contact our professional team.