Regulatory and Compliance

Technical writing and/or review of communications with and submissions to regulatory agencies, including IDEs, PMAs, 510ks and any required reports
Internal and external Quality Systems Audits according to US and EU regulatory requirements and/or unique client requirements
Remediation Programs (e.g. for actions required from warning letters, partner audits, internal audits, etc.)
Mock inspections in preparation for regulatory, certification, accreditation, or notified body inspections