FDA / MDR CE Regulation Consultancy
We have an international team that supports various manufacturers in the healthcare sector with Quality Management System (QMS) solutions, regulatory consulting, risk management support, clinical research, and evaluation services to ensure the security of their products, processes, systems, or services.
We provide expert advice on quality management system implementations according to ISO 13485:2016, 21 CFR 820, and MDSAP requirements. With decades of experience in internal and external audit support, we can develop a complete QMS system for your company and train your team to meet all requirements.
QMS
We offer extensive training sessions covering ISO, IEC standards, MEDDEV guidelines, MDSAP, and 21 CFR 820. Our comprehensive medical device training courses encompass various formats and can be tailored to your specific requirements. Each session integrates both theoretical knowledge and practical insights derived from extensive experience.
EDUCATION
Our compliance services provide comprehensive support to designers, developers, and manufacturers in product testing and troubleshooting. We offer a complete test lifecycle proposal that covers processes, personnel, and tools. Our services include test design, implementation, and documentation utilizing a proven methodology.
COMPLIANCE
We provide support for Clinical Trials according to ISO 14155 requirements. Our clinical experts have decades of experience in conducting medical device clinical trials aligned with global standards. We offer tailored support based on your needs, including literature-based analysis, Equivalence Demonstration, and Post-Market Studies.
CLINIC
We provide support throughout your product development cycle to overcome the complexities of creating a Risk Management File, which includes risk analysis, hazard analysis, production/post-production device monitoring, and more.
RISK MANAGEMENT
With our experience in Europe - MDD &MDR, USFDA - PMA &510(k), Health Canada, Singapore - HSA, Australia - TGA, Brazil - ANVISA, Colombia - INVIMA, India - CDSCO, Japan - PMDA Mexico - COFEPRIS, South Korea - KFDA approvals and other global market approvals, you are very close to every country in the world.