Brandwood Biomedical provides technical, regulatory and commercial advisory services to support the whole product life cycle in medical devices and in vitro diagnostics. We support regulatory approval and market access in global markets, with expertise in North American, European, Australian and Asian markets.
Recent projects include:
- Asian regulatory strategy for companion diagnostic.
- Negotiation of China standards compliance exemption and regulatory approval for imaging device.
- FDA IDE clinical trials submission and management of Australian trial arm for implantable heart assist.
- Vendor audit of Chinese subcontractors for suitability for US supply under QSR controls.
- Negotiation of single certificate Taiwan QSD for multi- site global manufacturer.