FDA Services
510(k)
As of October 1, 2023, the eSTAR form is mandatory - Axxos is happy to assist you with FDA approval.
Registration
Companies selling products in the USA directly or via their distributers must be registered with the FDA and comply with FDA requirements according 21CFR820. Once registered, the FDA can announce an inspection at your site any time. A solid preparation is key to survival.
US-agent and registration support
Together with Lance D. Johnson we offer US-agent services and support your company during establishment registration.
FDA readiness and mock-inspections
We offer FDA GAP-analysis and FDA readiness projects. Furthermore, Ex-FDA Inspector Lance D. Johnson collaborates with us offering FDA Mock-Inspections and US-Agent Services.
FDA readiness is a strategic action, showing the gap of the company to the FDA requirements. In a mock inspection the organisation and subject matter experts are trained to master a FDA inspection with success.
FDA inspection
During an inspection we take on operative roles such as:
- speaker
- translator
- frontroom or backroom organisation
After an inspection, we support you in communicating with the FDA and mastering any non-conformities.
Please do read our White Paper concerning this topic.