QMS & Global Regulatory ServicesEnsuring Continuous Compliance, Audit Readiness, and Operational Excellence.
A Medical Device Quality Management System (QMS)/ISO 13485 certification is not a one-time setup - it is an evolving framework that requires ongoing activity to remain compliant, efficient, and audit-ready.
At Medreg Consultancy, our Annual QMS Maintenance acts as your dedicated extension for quality maintenance. We take the annual compliance, document control, and regulatory tracking, allowing your team to focus on core business growth keeping things running smoothly while we safeguard your standards.
Core Pillars of Our QMS Maintenance Service
We provide an end-to-end service designed to keep your quality management system robust, updated, and fully aligned with regulatory requirements:
- Documentation Control & Updates: Outdated SOPs and uncontrolled documents are prime targets for audit findings. We manage your document lifecycle - creating, reviewing, updating, version-controlling, and archiving standard operating procedures, policies, and manuals seamlessly.
- Regulatory compliance Tracking: Standards are constantly revised - We actively track updates, revisions, and new guidelines from relevant regulatory bodies, notifying you promptly and adapting your QMS to maintain uninterrupted compliance.
- Pre-Audit Preparation: An upcoming audit shouldn’t cause panic. We conduct rigorous pre-audit reviews, evaluate your current state of compliance, check documentation readiness, and conduct mock audits to ensure your team is fully prepared and confident for external auditors.
- Internal Audits: An independent review is essential for true quality assurance. We plan, execute, and report on systematic internal audits across your organization, identifying operational activities, compliance gaps, and opportunities for process optimization.
- Corrective and Preventive Action (CAPA) Analysis: Mistakes happens, what matters is how you fix them. We help you investigate root causes, design effective Corrective and Preventive Actions (CAPAs), and verify their long-term effectiveness to prevent recurrence.
- Surveillance Audit Support: When your notified body conducts a surveillance audit, our experts stand by your side. We assist during the audit process, interpret auditor queries, and ensure smooth communication to secure a successful outcome.
- Support in Template Preparation: We design customized forms, logs, checklists, and protocols tailored specifically to your operational workflows to save valuable time with standardized, compliant, and ready-to-use templates.
- Record Filing & Management: Disorganized records lead to wasted time and audit penalties. We establish and maintain structured record-filing systems, ensuring that logs, batch records, training files, and equipment maintenance logs are instantly retrievable.
