MEDICAL DEVICES

Consulting services include:

• Provide insight in the FDA’s procedures, practices, policies and regulations
• Review and assist in the preparation of 510(k)s, PMA submissions, Device Master Files as well as annual, semiannual and other reports submitted to the FDA
• Review Standard Operating Procedures (SOPs), failure investigation reports, and third-party audit reports
• Assist in formulating a response to FDA pertaining to FDA-483s, Warning Letters, Application Integrity Policy Letters, recalls, and other regulatory communications from the agency
• Assist in drafting Corrective Action Plans, monitoring progress and accomplishments
• Provide guidance and advice during acquisition of new companies or products, outsourcing manufacturing or other activities. Conduct Due Diligence audits
• Provide proactive enforcement guidance as well as post-enforcement recommendations (seizure, injunction, and consent decree negotiations)
• Training