Success Stories

Brandwood Biomedical serves clients in the Medical Devices and Diagnostics Industries, from small startup developers and manufacturers, to multinational and listed companies.   We have also served investors and government authorities. These are some of our recent successes.

• Preparation of FDA IDE clinical trials submission for a heart assist device
  
• ISO 14971 risk management for a complex disinfector device
  
• Market intelligence report - regulatory requirements in Japan and China
• Regulatory Strategy advice for Companion diagnostics marketed across Asia
• Reimbursement submissions for Active Implant Medical Device
  
• Technical and regulatory due diligence for investors in a cardiovascular implant
  
• Developed and implemented quality systems compliant with ISO 13485 and FDA 21CFR 820 for a specialist moulding plant
  
• Preparation of Technical Files leading to Australian, CE mark and Canadian approvals
  
• Management of a corrective action program following an adverse regulator audit, with successful recertification
  
• Preparation of a preclinical data package as part of licensing of a device to a multinational manufacturer
  
• Companywide training program on ISO 13485 compliance for a medical disposables manufacturer
  
• Global regulatory strategy for a drug delivery device manufacturer

Contact us for more details of our capabilities and references.