We help you navigate complex regulatory controls for all classes of devices. Our work includes leading inhouse training on enforcement priorities and regulatory requirements; performing mock audits to help prepare for inspections; developing standard operating procedures for production facilities and clinical study sponsorship; and developing comprehensive corrective action plans to address audit and inspectional findings. We routinely help companies respond to Warning Letters, Form 483s, and suspension or withdrawal of CE Certificate of Conformity letters. We have extensive experience working with companies on government investigations, criminal prosecutions, seizure and injunctive actions, civil money penalty actions, and import alerts. We review advertising and promotional materials to ensure ongoing compliance with applicable regulations and policies.
