Amin Talati provides legal advice on medical devices to large corporations and small start-up companies. Firm lawyers have extensive experience in counseling and assisting on all aspects of medical device development.

Our Medical Device Services Include:

• Advising on clinical trials of medical devices under the investigational device exemption (IDE) regulations
• Advising on FDA classifications of medical devices and various product liability and labeling issues
• Preparing and filing of pre-market authorization applications (PMAs), 510(k) Notifications and Humanitarian Device Exemptions (HDEs)
• Preparing and filing establishment registration applications
• Counseling on the marketing of drug-device combination products
• Assisting in compliance issues with respect to Medical Device Reports (MDRs), product recalls, market withdrawals, FDA site inspections and Quality System Regulation (QSR) requirements
• Developing pre-market approval and FDA clearance strategies
• Coordinating communications with the FDA
• Drafting and negotiating clinical trial, lab services, manufacturing and supply agreements
• Monitoring updates in medical device legislation and providing strategic advise on implementing changes in law to your medical device practice
• Defending product seizure and criminal actions