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Brandwood Biomedical has served the medical devices & IVD industry since 2000. Services include regulatory submissions (TGA, US FDA 510(k), CE, China FDA and Taiwan FDA), postmarket support, ISO 13485 / 21CFR quality systems and preclinical (ISO 10993 biocompatibility) and clinical evaluation and reimbursement. Our expert multilingual regulatory consultants in Australia, New Zealand & China are led by professionals with international networks and decades of experience to provide seamless regulatory compliance across global markets.
One Data set – for the world. If you need access to a single market or need to achieve multiple market approvals, let us show you how to do this with a single technical file. Ask us about our track record of successful product approvals in the USA, Europe, China, Australia and more.
Product recall? Warning Letter? Audit failure? Cancellation of Registration? Don’t Panic! We are experienced in dealing directly with regulators to resolve postmarket issues smoothly and with minimum fuss.
A quality culture adds real value to your business and ensures compliance runs smoothly. Let us help you – with individual processes, independent internal audit support or building a complete system. We are experienced in ISO 13485 and 21CFR 820 (QSR) for design and manufacturer and in ISO 17025 and 21CFR 58 for laboratories.