Brandwood Biomedical Securing your compliance
Brandwood Biomedical is a specialist regultaory, quality and technical consultancy serving the research based medical device and diagnostics industry.
The founder and 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 one of the Biomaterials and Engineering Laboratories at the Therapeutic Goods Administration - the Australian national regulatory authority for medical devices and pharmaceuticals.
Main business focus/
Listing by sector:
- Service Provider
- Medical Devices
- Research Organisation
Brandwood Biomedical brings to its clients a 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.
We also bring to our clients our global network of contacts in government and industry.
We help our clients to:
- develop technical and regulatory strategy;
- 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, USA, Europe and other jurisdictions - with particular expertise in SE Asia;
- develop skills through training and short courses in regulatory affairs and medical device development.
We can provide technical and regulatory support to match the 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 system implementation;
- provision of tailored training services.
Brandwood Biomedical is proud to have served the following Australian and International Clients.
Australian Orthopaedic Innovations
CSIRO Division of Biomolecular Engineering
John Hunter Hospital
Lipid Sciences Inc. (USA)
National University of Singapore
Queensland Biomedical Fund
Royal Perth Hospital
Sunshine Heart Company
University of New South Wales
Consultancy and training for government agencies and industry associations:
Therapeutic Goods Administration
Indonesian National Agency for Drug and Food Control
Singapore Health Sciences Authority
|Contact person||Arthur Brandwood|
|Job Title||Managing Director|
|Address||Suite 4.08, 460 Pacific Highway|
|State||New South Wales|
|Phone||+61 2 9906 2984|
|Fax||+61 2 8580 4613|