A Range of Medical Device Consulting Services

• Quality Management – Design Assurance, Quality Systems, Operations Quality

• Regulatory Affairs Management – FDA Submissions, Notified Body Management

• Quality System Development - ISO 13485, 21 CFR 820

• Product Development/Design Controls – Project Management, Quality Engineering

• Risk Management – ISO 14971

• Operations Management - DMR development, EH&S

• Clinical study management – ISO 14155

• Internal Auditing

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