ELV QA & RA SOLUTIONS LTD. DELIVERS NEARLY 20 YEARS OF EXPERIENCE IN AIDING CUSTOMERS WITH THEIR QUALITY ASSURANCE, REGULATORY AFFAIRS AND COMPLIANCE PROJECTS.
Focused on the Pharmaceutical, Medical Device and In-Vitro Diagnostic (IVD) industries, our motivated and highly trained experts provide the knowledge and competence necessary in leading the way through international standards requirements, submissions and certification. Providing a wide and full range of services, we are a “One Stop Shop” for professional compliance projects.
Facilitating all processes from regulatory strategy development through preparation of submission packages; quality system establishment, audits and certification, our customers benefit from our global expertise and proven record of success in challenging regulatory projects. We are dedicated to achieving prompt and precise results, optimizing product time to market and delivering a high ROI. Backed with experience and the commitment to first level service, we recognize the importance and value of building a balanced certification program with full documentation, reporting and coordination of all processes.
AT ELV QA & RA SOLUTIONS LTD. WE BELIEVE IN FLEXIBILITY OF WORK MODELS, ADAPTING TO CUSTOMERS SPECIFIC NEEDS
ELV QA&RA Solutions is an ultimate answer to customers looking for outsourcing of the Quality Management System (QMS) maintenance, preparation of design control documentation, software and hardware verification and validation, preparation of risk management and usability files, compliance trainings and mock-up audits, achievement of product certification and international marketing approvals. Successfully assisting our clients through audits (assessment, customers, suppliers, FDA, ISO, CE, MDSAP and etc.), QMS establishment and implementation processes, ISO, FDA, CE and other certification activities ELV team works with full personal commitment and professionalism. Our global expertise and connections extend beyond ISO and FDA, we are well experienced with international product registrations including: EU medical device and IVD Directives and Regulations (MDR), China SFDA, Australia TGA, Brazil, Canada CMDR / CMDCAS / CAMCAS, Central and South America, Russia Device Registration and Japan MHLW requirements
We unwaveringly stand behind our commitment to remain informed on the changes in global regulatory environment, delivering the best quality service in a cost-effective and time-saving manner and ensuring successful product releases for each and every one of our customers.
