Every medical device manufacturer regardless of company size or the sophistication of their product will at some point find themselves out of compliance with some regulation. It may be their own standards and specification, other internal compliance requirements or regulatory infractions including FDA Form 483’s, Warning letters, Corporate Integrity Agreements, Conformity Assessment, enforcement action and decrees, QSR, ISO 9000 | 13485, etc. Whether you are manufacturing and marketing in just one country or region or involved in multi-national manufacturing and marketing, it can require knowledge of and compliance with hundreds or even thousands of regulations and standards.
Remediation to recover full compliance requires a documented plan of action. Non compliances and violations may be isolated incidents or may be systemic failures. Either way manufacturers need to: understand cause(s), examine control systems that may have failed, review potential vendor/raw material/ subcontractor issues and establish a plan that will not only resolve the particular incident but establish corrective and preventive actions. In this process, knowledge of all regulations and standards for all countries where a medical device is marketed is crucial to ensure a remediation plan will be successful and continue to work for the long term.
Quality First International has designed and led remediation programmes for companies ranging from very small to multi-national blue-chip corporations. Our knowledge of medical devices, how they function, how they are used, manufacturing processes and raw materials, vendor and subcontractor requirements as well as the regulations and requirements of all major countries make us the ideal partner to assist in your remediation programme. We also have significant experience communicating and negotiating with regulatory agencies and can act as your liaison or advisor in all such interactions and communication.
QFI remediation support includes:
- Design, implement and manage remediation and compliance programmes to bring you into full compliance
- Analysis and response to FDA Form 483 observations, Warning Letters, EU Conformity Assessment enforcement and other compliance citations.
- Navigating the FDA regulatory process to assure you meet all requirements for product clearance and approval
- Formulating timelines meeting agency expectations & help implement improvements ensuring total compliance
- Design and supervise development of systems and processes to control, manage or remediate violations
- Serving as interim regulatory staff and/or Compliance Officer
- Serving as independent review organization (IRO) to:
- Evaluate compliance programmes
- Develop effective code of ethics & compliance programmes
- Act as internal monitor, develop monitorship work plans to assure long-term and continued compliance
- Analyse corporate culture related to quality & compliance and assist in the culture change process
- Assist with creation and implementation of corporate Integrity Agreements
- Technical-level support for remediation and litigation projects, including remediation system design, determination of regulatory applicability and conduct of feasibility or cost-benefit studies
- Examination of problem origin including thorough analysis of non-conformity, identify required actions, plan and manage a corrective and preventive action program
- Identification of potential business improvements
- Assistance in establishing and maintaining credibility with customer base as well regulatory agencies
- Coordination of on-site activities for clean-up of remediation projects to ensure compliance with laws, regulations, standards or other requirements
- Inspection of sites including suppliers and subcontractors to assess requirements or monitor clean- up progress
- Training of on site staff including management as well as suppliers and subcontractors on operations and maintenance of remediation system