Navigating Significant Changes in ISO 13485 Audits
Dear ISO 13485 Auditors,
At International Associates, we champion quality and safety in medical device manufacturing. Our commitment extends to auditing significant changes within your Quality Management System (QMS), aligning with ISO 13485 standards.
Audit Expectations: Adaptability is key—we ensure your QMS meets current and future regulatory demands by thoroughly evaluating your QMS processes and assessing the implications of significant changes on ISO 13485 compliance.
Global Compliance: Global readiness is our compass. Acknowledging diverse medical device regulations, including those in the EU, Canada, and beyond, we evaluate how your organisation defines and oversees significant changes across different jurisdictions.
Decision Trees: Shedding Light – Embraced within the EU guide, decision trees act as illuminating guides. Equipped with detailed directives, we meticulously examine your QMS documentation. Transparent evidence of decision-making guarantees compliance and upholds the integrity of your devices.
Partnership for Excellence: Beyond audits, we’re your navigators in the ISO 13485 landscape. Expect insights, feedback, and continuous improvement as we uphold the highest standards. Together, let’s elevate quality, safety, and efficacy—meeting patient expectations and regulatory requirements.
If any aspect remains unclear, don’t hesitate to seek clarification. Let’s foster a culture of precision and understanding.
#InternationalAssociates #ISO13485 #Healthcare #MedicalDevices #Manufacturing #Innovation #QualityAssurance #AuditingExcellence
https://health.ec.europa.eu/system/files/2023-09/mdcg_2020-3_en_1.pdf
