ISO 13485 is the global standard for Quality Management Systems (QMS) in the medical device industry. Certification ensures your processes meet regulatory requirements, promote patient safety, and enhance market access. dicentra provides expert guidance and independent assessments to simplify your journey to compliance.

• Training on ISO 13485 Requirements: Comprehensive training tailored to your team’s needs, ensuring a clear understanding of ISO 13485 standards and best practices.
• Gap Assessments for Compliance Readiness: Identify areas for improvement within your existing Quality Management System (QMS). We provide actionable insights and strategies to address compliance gaps efficiently.
• Pre-Certification Audits: Prepare for success with thorough evaluations of your processes, identifying potential non-conformities and areas requiring enhancement before your official certification audit.
• Certification Audits: Receive independent, third-party verification of your compliance with ISO 13485 standards. Our experienced auditors ensure a transparent and reliable certification process.
• Ongoing Post-Certification Support: Stay compliant with routine surveillance audits, process optimization recommendations, and continuous improvement guidance. We help you maintain your certification and adapt to regulatory updates seamlessly.