Services
With over 20 years of experience in the MedTech industry, Niki provides comprehensive services across Quality, Regulatory, and Clinical areas. Business-balanced and tailored solutions help manufacturers navigate the complex landscape of U.S. FDA and EU medical device regulations, ensuring compliance and market success.
Each service is designed to ensure that your product is fully compliant and positioned for success in the market. Whether you need support with quality management, regulatory strategy, or clinical development, we provide the expertise to guide you through every step.
Regulatory
Navigate the complex regulatory landscape with our comprehensive Regulatory Services. From pre-market application support to technical leadership, we guide you through every step of the submission process, ensuring that your regulatory strategy aligns with your business objectives and market goals.
Quality
Quality Services are designed to help you implement, update, and expand your Quality Management System in compliance with QMSR, ISO 13485, and relevant standards. Whether you’re adapting to new regulations or expanding your scope, we provide the expertise needed to ensure robust and effective quality processes.
Clinical
Clinical Services include strategic support for clinical development, post-market follow-up (PMCF), and clinical evidence assessment. We help you design, implement, and manage clinical studies and PMCF activities and update Clinical Evaluation Reports (CERs) to ensure that your product meets all regulatory, clinical, and scientific requirements.
Sol MedTech 