Brandwood Biomedical
Brandwood Biomedical provides technical, regulatory and commercial advisory services to support the whole product life cycle in medical devices and diagnostics and to achieve regulatory approval in global markets, with particular expertise in Asian markets.
The Principal, Dr Arthur Brandwood has over 20 years experience in the medical technology field in commercial product development, academia and government including as Director of Devices Registration and Assessment, and of the Biomaterials and Engineering Laboratories at the Therapeutic Goods Administration – the Australian national regulatory authority for medical devices and pharmaceuticals.
Competitive advantages
Brandwood Biomedical provides an unrivalled combination of extensive product development technical expertise with detailed knowledge of current risk based regulatory requirements and procedures including application of quality and technical standards and conduct of risk assessments.
Services
We can help you to:
- develop the right technical and regulatory strategy for your business;
- achieve appropriate solutions for preclinical and clinical product testing,
- conduct ISO 14971 risk management
- develop and implement ISO 13485 quality systems
- prepare regulatory submissions for Australia, SE Asia, USA and Europe
- develop your skills through training and short courses in regulatory affairs and medical device development.
We can provide technical and regulatory support to match your stage of development and budget – including:
- initial strategic assessments of regulatory pathways,
- project based activities such as risk assessments, management of device or materials testing or preparation of specific regulatory submissions
- continuing technical and regulatory support and guidance on postmarket systems, technical file maintenance and quality systems implementation