Post Market Compliance & Surveillance
No-one likes surprises!
We work with you to ensure proactive, continuing compliance and manage emerging issues to minimise disruption to your business.
Recent examples of our work include:
- Negotiating recalls with multiple agencies for a misformulated product.
- Negotiating continuing registration and subsequent renewal for a device in China after discovery of major faults in original registration.
- Support to orthopaedic manufacturer in response to adverse findings in the National Joint Registry.
- Filing of adverse event reports
- Upgrades to postmarket compliance processes
Need assistance with your Global Medical Device and IVD Regulatory Services?
We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)