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- Senior Consultant – Regulatory Affairs (Beijing)
- China CFDA Updates Animal Derived Biomaterials Guidance
- European Devices Reforms – How will Australia Keep Up?
- Tic – Toc: time is running out on critical TGA consultations. Be sure you have your say
- So what next for FDA oversight of US Lab Developed Tests?
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.
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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.