Gap Assessments & Audits

The range of requirements that a manufacturer must meet is constantly changing, including new approaches from FDA ("current thinking") or revised international standards. A manufacturer must stay current with these requirements. MCRA performs either a gap assessment or an audit to assist a manufacturer in closing the gaps between the manufacturer’s quality system and the changed requirements. MCRA ensures that any quality system changes are assessed for their impact on both the quality system and the manufacturer's devices. 

Services We Offer

  • Gap Assessment

    MCRA will provide an associate with credentials who will perform an assessment to either FDA compliance, or international standards.  Examples of these assessments include:

    • ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
    • Medical Device Single Audit Program (MDSAP)
    • EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices
  • Audits

    Once a quality system is in place, manufacturers must conduct routine audits to ensure their system is compliant and effective. Without regular monitoring, there may be a reduction in product quality or a lack of process improvement, resulting in either a possible loss of third-party certification or FDA enforcement actions. MCRA’s experts can assess your compliance and prepare you for FDA inspections and notified body audits to keep you in compliance.

    • Perform mock FDA inspections to assess QSR compliance, including mock Pre-Approval Inspections (PAIs) for PMA submissions
    • Perform supplier audits, reducing your internal cost by outsourcing this requirement
    • Perform internal audits, reducing your internal cost by outsourcing this requirement
  • Problem Resolution

    Medical device manufacturers are required to comply with FDA regulations regarding how device issues are recorded and resolved. MCRA’s experts have worked with FDA and can help accomplish everything from creating a complaint process to resolving an FDA warning letter.

    • Assist in creating complaint processes, including FDA medical device reporting (MDR) to comply with 21 CFR Part 803, and improving complaint investigations
    • Management of recalls in accordance with 21 CFR Part 806
    • Assist in creating processes for vigilance reporting (VR) for CE-marked devices
    • Improve conforming product processes
    • Improve document control systems, including compliance with 21 CFR Part 11 for electronic signatures and electronic record-keeping
    • Improve CAPA processes, which are among the most common sources of FDA 483s
    • Resolve FDA 483s and warning letters with quality system updates
    • Resolve notified body ISO 13485 audit observations
  • Supplier Management

    Suppliers are an integral part of all manufacturing processes, but for medical device companies, FDA’s QSR makes choosing and monitoring suppliers a challenge. MCRA’s experts can help with the entire process, from selection to monitoring and contractual agreements. Let our experts make sure your products are made to meet compliance standards.

    Evaluate or create a supplier management program including:

    1. Selection process
    2. Evaluation process
    3. Monitoring process
    4. Supplier quality agreements
    5. Monitoring suppliers by performing audits
  • Due Diligence

    Today it is common for a manufacturer to either be acquired or to acquire another manufacturer. MCRA assists either a selling organization or a buying organization in determining the risk of an acquisition. Our team will assist your firm by performing due diligence on the suitability of the design records, the manufacturing system, the complaint handling system, quality records, and other quality system requirements. MCRA has assisted clients in their due diligence efforts for the following types of devices:

    • Orthopedic implants
    • Instrumentation
    • In-Vitro Diagnostics
    • Acquisition of manufacturing facilities
    • Manufacturing transfers
View Contact
Dan Goldstein

Dan Goldstein

Manager, Quality Assurance