Medical Devices GxP Compliance Audits and Consulting

​Internal Audits (ISO 13485 / FDA QSR)

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• Activities:

  • Review documentation (SOPs, training records, risk assessments, CAPAs) for completeness and compliance.

  • Conduct process audits for key areas such as design control, production, labeling, and complaint handling.

  • Verify product traceability using batch records and device history files (DHF, DMR, DHR).

  • Evaluate training effectiveness by sampling staff knowledge on critical SOPs.

• Example: Internal audits reveal gaps in design control documentation and improper change management. A corrective action plan is initiated to revise procedures, preventing future non-compliance.

• Outcome: Improves preparedness for external inspections and ensures ongoing compliance with ISO 13485 / FDA QSR.

 

Supplier and Vendor Audits

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• Activities:

  • Assess vendor capabilities, focusing on material traceability and quality systems.

  • Review supplier audit reports, CAPA history, and compliance with contracts.

  • Implement a risk-based approach by ranking suppliers based on criticality to the product (e.g., Class III implantable device vs. packaging supplier).

• Example: A critical component supplier shows poor CAPA handling. You recommend switching to a supplier with stronger quality controls, minimizing the risk of defects.

• Outcome: Ensures reliable supply chains and prevents disruptions due to non-conforming products.

 

Mock FDA / Notified Body Audits

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• Activities:

  • Develop realistic scenarios to test staff readiness and responses to auditors.

  • Audit areas often scrutinized by regulators, such as complaint management and CAPA effectiveness.

  • Provide coaching on how to answer questions confidently and accurately during inspections.

• Example: During a mock audit, deficiencies are found in complaint trending processes. The company revises its procedures and retrains staff, preventing potential 483 observations during the real FDA inspection.

• Outcome: Reduces risk of regulatory findings and builds confidence among employees for future inspections.

 

Compliance Audits for EU MDR / IVDR Transition

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• Activities:

  • Review technical documentation (e.g., CERs, risk management files) for MDR alignment.

  • Check PMS system integration with Field Safety Corrective Action (FSCA) requirements.

  • Evaluate whether the company’s UDI system is compliant with MDR standards.

• Example: The audit identifies gaps in clinical evidence for a legacy product under MDR requirements. You assist the company in generating new clinical data to meet compliance.

• Outcome: Facilitates a smooth transition to MDR, avoiding costly interruptions to the European market.

 

Regulatory Compliance Audits (Global)

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• Activities:

  • Conduct audits for multi-country compliance, including MDSAP and Japanese PMDA requirements.

  • Evaluate labeling compliance across different markets (e.g., EU MDR, FDA UDI).

  • Assess complaint management systems for international adverse event reporting obligations.

• Example: An MDSAP audit reveals inconsistent document control across facilities. A harmonization project is initiated to standardize processes globally.

• Outcome: Supports seamless compliance across multiple jurisdictions, minimizing regulatory risks.

 

Pre-Acquisition or Merger Due Diligence Audits

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• Activities:

  • Perform in-depth QMS reviews, focusing on the compliance history of the target company.

  • Identify open CAPAs, recalls, or regulatory actions that could pose risks.

  • Evaluate the quality culture alignment between the companies.

• Example: The due diligence audit identifies open FDA 483 observations at a target facility. You recommend mitigation strategies before finalizing the acquisition.

• Outcome: Reduces the likelihood of post-acquisition surprises and ensures a smooth integration process.

​Quality Management System (QMS) Implementation and Enhancement

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• Activities:

  • Develop tailored SOPs for document control, change management, and CAPA.

  • Implement a digital QMS platform for streamlined document management and audits.

  • Train staff on their roles and responsibilities within the QMS.

• Example: After implementation, the company experiences a 25% reduction in documentation errors and improved audit readiness.

• Outcome: A robust and scalable QMS that supports company growth and compliance.

 

FDA Inspection Readiness Programs

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• Activities:

  • Develop inspection playbooks detailing roles, responsibilities, and communication strategies.

  • Organize mock interviews with key personnel to simulate inspector interactions.

  • Prepare inspection binders with design controls, batch records, and complaint logs.

• Example: During a surprise FDA inspection, staff follow the playbook seamlessly, leading to a successful outcome with no 483 observations.

• Outcome: Increased confidence and proactive management during regulatory inspections.

 

CAPA Management and Root Cause Analysis Consulting

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• Activities:

  • Develop templates and workflows for effective CAPA documentation.

  • Conduct root cause analysis using 5-Whys, Fishbone Diagrams, and Pareto Analysis.

  • Train staff on CAPA effectiveness checks to prevent recurrence of issues.

• Example: CAPA improvements lead to a 15% reduction in deviations within 6 months.

• Outcome: A closed-loop CAPA system that drives continuous improvement.

 

Risk Management (ISO 14971 Compliance)

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• Activities:

  • Develop Risk Management Plans and conduct Risk Benefit Analysis.

  • Perform FMEA on design and production processes to identify potential failures.

  • Integrate risk management into PMS to ensure ongoing risk assessments.

• Example: Identifying a potential design flaw early avoids a costly recall after product launch.

• Outcome: Reduces risks across the product lifecycle, ensuring patient safety.

 

Post-Market Surveillance (PMS) and Vigilance Systems Setup

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• Activities:

  • Establish complaint handling processes for tracking and resolving issues.

  • Develop PSURs and trend reports to monitor product performance.

  • Create systems for rapid reporting of adverse events to regulators.

• Example: A PMS system identifies an early trend of adverse events, enabling timely corrective action.

• Outcome: Ensures product safety and compliance with regulatory vigilance requirements.

 

Training Programs for Compliance and Quality Excellence

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• Activities:

  • Develop tailored training modules for employees on internal audits and CAPA.

  • Conduct hands-on workshops for risk management and root cause analysis.

  • Provide ongoing training on global regulatory changes.

• Example: After CAPA training, employees identify and resolve a recurring deviation, preventing further incidents.

• Outcome: A well-trained workforce that promotes a culture of quality.

 

Global Regulatory Strategy Development

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• Activities:

  • Identify appropriate regulatory pathways (e.g., 510(k), PMA, CE Marking).

  • Prepare technical files and design dossiers for submission to various regulators.

  • Provide strategic advice on market entry and product launch.

• Example: The company successfully launches its product in the US and EU simultaneously by following a harmonized regulatory strategy.

• Outcome: Faster time-to-market with reduced regulatory hurdles