Driving Compliance and Improvement
Driving Compliance and Improvement
We offer thorough internal audits designed to help your business achieve and maintain compliance with industry standards and regulations. Our audits go beyond simple checklists—they uncover gaps, identify opportunities for improvement, and provide actionable insights to strengthen your Quality Management System (QMS) and overall operations.
Internal audits are a vital tool for ensuring compliance, minimizing risks, and fostering continuous improvement. By proactively assessing your processes, we help you address potential issues before they become critical. Our goal is to empower your team with the knowledge and tools to build a resilient and compliant QMS.
For businesses navigating the transition to MDR or IVDR, audits and gap analyses play a crucial role in aligning existing systems and technical documentation with the updated regulations. This ensures your organisation remains compliant and market-ready.
We collaborate with your team to provide tailored, hands-on support. Our role is to advise and empower you rather than take over the process, enabling your team to build confidence and independence.
Gap Analysis: Pinpointing areas where your current operations fall short of regulatory requirements or industry standards.
Process Review: Assessing workflows across departments to ensure compliance, efficiency, and traceability.
Risk Identification: Highlighting potential risks that could affect compliance or product quality.
Actionable Recommendations: Delivering clear and practical solutions to address gaps and enhance your operations.
ISO 13485 Compliance Audits: Focused audits to ensure adherence to the requirements of ISO 13485:2016, including documentation, risk management, and design control processes.
Gap Analysis for MDR/IVDR: Conducting detailed assessments of your existing QMS and technical documentation to identify gaps relative to MDR or IVDR requirements.
Process and Documentation Audits: Comprehensive evaluations of your procedures, records, and workflows to ensure compliance and efficiency.
Software and Systems Audits: Auditing software and electronic Quality Management Systems (eQMS) to ensure they meet regulatory requirements and support business processes effectively.
Technical Documentation Audits: Reviewing technical documentation to ensure it meets the updated standards of MDR/IVDR, including clinical evaluation and post-market surveillance plans.
Ready to strengthen your compliance processes?
Contact us to learn more about how we can support your business.