Our Quality Assurance Experience
Medical device companies rely on us to meet or exceed the quality assurance standards set by the FDA and other regulatory bodies. Our strong experience working with regulators and Notified Bodies helps to guide you through the processes for product review, approval, and regulatory compliance. We reduce your compliance stresses and help bring your device to market, and then maintain quality assurance requirements by adhering to standards to ensure uninterrupted market presence.
Comprehensive Quality Assurance Services
Medical device companies must adhere to strict FDA and global quality assurance (QA) requirements to ensure product consistency and safety. Failing to meet quality assurance standards costs small and large device firms both time and money.
Key Quality Assurance Offerings
QUALITY SYSTEMS & PROCESSES
• Creating complete, new quality systems
• Gap assessments and streamlining of existing quality systems
• Updating quality systems for new regulations, standards, and guidance documents
• Validating quality system software (ERP, electronic signatures, temperature control, etc.)
AUDITS
• Mock FDA inspections (PMA pre-approval, routine, and for-cause)
• Internal audits for regulatory compliance
• Supplier audits for the quality of purchased goods and services
DEVICE DESIGN
• Leading and supporting design teams for new and updated Design History Files (DHFs)
• Validating manufacturing processes
• Creating and updating Risk Management files
• Remediating non-compliant DHFs and DMRs
BUSINESS NEEDS
• Due diligence of quality systems and DHFs prior to company or device acquisition
• Resolving quality deficiencies to improve a company’s or device’s value for acquisition
• Moving or combining manufacturing lines for acquisitions and facility upgrades
FDA-FACING SUPPORT
• Writing GMP Modules for PMA submissions
• Initiating and maintaining FDA recall activities
• Submitting Medical Device Reports (MDRs) to FDA
• Submitting Unique Device Identification (UDI) codes to FDA
• Submitting Establishment Registrations and Device Listings to FDA
OUS MARKETS
• Preparing for Notified Body and MDSAP audits
• Obtaining 13485:2016 certification
• Providing Quality support for Technical Documentation