CMD Consulting can help companies located in Scandinavia and Europe in understanding and responding to US Medical Devices regulatory requirements, especially with respect to:
reviewing draft submission documentation such as Pre-Market Notification 510(k) clearance and Investigational Device Except (IDE) applications
establishing sufficient documentation to meet FDA Software Validation requirements
establishing sufficient documentation to meet FDA requirements for complex devices (Combination products) and sterile devices
assisting in the development of labelling, including user manuals, that meets US regulatory and customer requirements
for selected projects, directly translating or arranging for the translation of documentation and labelling required for the submission
obtaining applicable guidance documents and standards
