Callisto Consulting can support you in:
- Guidance on the appropriate legislation covering these products in different markets.
- Classification advice.
- Provide advice on data requirements and the regulatory activities required.
- Liaise with the regulatory bodies where appropriate.
- Submit and manage any regulatory applications that are required.
- Prepare technical files and support approval by Notified Bodies where needed.
- Medical Device market surveillance including Incident Reports and Field Safety Corrective Action.