With offices in both the EU and USA, we are uniquely positioned to offer our clients a global perspective and unparalleled expertise in the ever-evolving world of regulatory affairs and information security.
We offer a wide range of services, including MDR and FDA compliance assistance, ISO 13485 implementation/internal audits, PRRC and US FDA Agent services, ISO 27001 implementation/internal audits, risk management and training, documentation support, and much more.
As your trusted partner, we also have partnerships with experts in various aspects of medical device development, including design, clinical trials, and EQMS software, allowing us to offer comprehensive support throughout the entire medical device development process.
Contact us today to learn more about how we can support your medical device company and achieve compliance and information security excellence. Let us help you succeed!