Audit and Inspection Services

Preparing for regulatory audits and inspections is critical to maintaining compliance and protecting the reputation of your medical device company. Global regulatory authorities like the FDA, the EU MDR, and other international bodies conduct routine and surprise inspections to ensure manufacturers meet stringent safety and quality standards. Failing an inspection can result in warning letters, fines, product recalls, or even facility shutdowns.

Our audit and inspection readiness services are designed to prepare manufacturers for every stage of the audit process. We help you assess your current compliance status through thorough gap assessments and mock audits. These assessments help identify any deficiencies or non-conformances that need addressing before the official regulatory inspection. Our experts simulate real-world inspections, giving you a comprehensive understanding of the areas where your company is meeting standards and where improvements are needed.

We assist manufacturers in creating a comprehensive audit playbook that covers every aspect of the inspection process. This playbook serves as a guide for both your team and external auditors, ensuring that every step of the inspection is well-organized and streamlined. We provide support both in the "front room" and "back room" during audits, managing communication between your team and regulatory inspectors. For FDA inspections, we offer back-room support from former FDA officials, helping to manage the flow of information and ensure smooth communication.

For companies operating in multiple regions, the Medical Device Single Audit Program (MDSAP) offers an efficient way to meet compliance standards across several jurisdictions with just one audit. Our team helps you prepare for MDSAP audits by ensuring your quality management system (QMS) and documentation are fully aligned with the program’s requirements. We also help streamline the audit process by ensuring all necessary documents, procedures, and records are easily accessible and ready for inspection.

Our services include:

• Gap Assessments: Identify compliance and QMS gaps through a detailed review of your processes and documentation.
• Mock FDA Inspections: Simulate an FDA inspection to prepare your team for all stages of the audit process, including pre-inspection activities and strategic back-room support.
• FDA Readiness Support: Comprehensive support to ensure your organization is fully prepared for an FDA inspection, from documentation reviews to staff training.
• Mock European Regulatory Agency Audits: Prepare for EU MDR, IVDR, and other European regulatory audits with tailored mock inspections.
• Data Integrity Audits and Assessments: Evaluate your data integrity systems and processes to ensure compliance with global regulatory requirements.
• Regulatory Filing Audits and Assessments: Review your regulatory submissions and filings to confirm accuracy and alignment with regulatory standards.
• ISO 13485 and QSIT Audits: Ensure compliance with ISO 13485 and QSIT requirements through structured audits.
• Compliance Audits to EU MDR: Assess your compliance with the latest EU MDR standards through in-depth audits.
• Supplier Audits: Perform thorough audits of your suppliers to ensure they meet regulatory and quality management standards.
• Due Diligence Assessments: Conduct regulatory and compliance assessments as part of mergers, acquisitions, or other business transactions.
• Company-Wide Audit Management: Manage your entire audit program, including scheduling, auditing, and reviews, to ensure a streamlined and cohesive audit strategy.

In addition to pre-market and routine inspections, our services extend to helping manufacturers manage post-market audits and inspections. Regulatory bodies like Health Canada and Japan’s PMDA frequently conduct post-market inspections to verify that devices continue to meet safety and efficacy standards after they have been introduced to the market. We help you prepare for these inspections by ensuring your post-market surveillance (PMS) data, adverse event reporting, and other required records are up to date and fully compliant.

In the event of non-conformances or deficiencies identified during an audit, our team can assist in crafting and submitting comprehensive responses to regulatory agencies. We provide guidance on corrective and preventive actions (CAPA) and work with your team to ensure the necessary changes are implemented in a timely manner to avoid future compliance issues. Whether preparing for an initial audit or managing post-market compliance, we are your partners in ensuring successful inspections.

We have compiled a list of articles and training courses on the issue of auditing to help you and your colleagues.

Medical Device Regulatory Requirements: Five-Course MDSAP Bundle
This 10-hour course bundle provides a comprehensive overview of the medical device regulatory requirements for all five countries currently participating in the MDSAP program, a requirement for all manufacturers utilizing audits.

Key FDA Policies, Procedures and Practices Before, During and After Medical Device Manufacturer Inspections
A behind-the-scenes look at how FDA medical device inspections are planned, conducted, and managed.

Driving Growth: The Power of Outsourcing Internal Audits in Life Sciences
In the highly regulated life sciences industry, internal audits play a crucial role in ensuring compliance with various standards, and regulations. However, internal audits can be complex, and require specialized expertise and significant time and resources.