Independent auditing services for medical device manufacturers, conducted by certified lead auditors
EUMEDIQ provides independent auditing services across quality management systems ISO 13485 quality management system for medical devices and ISO 27001/27002 information security management, as well as regulatory compliance, supplier audits, internal audit programmes, mock audits, and gap assessments against different audit criteria.
EXPERIENCED EXPERTS
Certified lead auditors for management systems in the MedTech industry
EUMEDIQ's lead auditors provide independent auditing services across quality management systems, information security management, and regulatory compliance, covering supplier audits, internal audit programmes, mock audits, and gap assessments.
3+
Audit frameworks. ISO 13485, MDSAP, ISO 27001, QMSR (former US 21CFR Part 820) and regulatory gap assessments under MDR, IVDR, HIPAA, and NIST 2.
ISO 19011
auditing standard. All EUMEDIQ management system audits conducted in accordance with the internationally recognised auditing standard.
EU · UK · CH
Auditing services covering the regulatory requirements of the European Union, United Kingdom, and Switzerland.
ISO 19011 WORKFLOW
A structured and transparent audit process, carried out in accordance with ISO 19011
All EUMEDIQ management system audits are conducted in accordance with ISO 19011, the internationally recognised standard for auditing management systems. The workflow covers every stage of the audit process, from initial scope and requirement definition through to execution, reporting, and follow-up verification of corrective action effectiveness.
Our lead auditors guide manufacturers through each individual process step, ensuring a comprehensive understanding of the audit scope, findings, and recommended corrective actions at every stage of the engagement.
STEP 1
Audit plan
The audit plan defines the scope and requirement definitions for the engagement, establishing the audit criteria, applicable standards and regulations, and the specific areas and processes to be covered in consultation with the manufacturer.
STEP 2
Audit plan agreement
The audit plan is formally agreed with the manufacturer prior to execution, ensuring the scope, objectives, and timeline are clearly understood and accepted by all parties before the audit begins.
STEP 3
Checklist preparation
A dedicated audit checklist is prepared specifically for the engagement, tailored to the agreed scope and applicable requirements, ensuring a structured and consistent approach to audit execution across all relevant areas and process steps.
STEP 4
Execution
The audit is conducted on-site or remotely by EUMEDIQ certified lead auditors in full accordance with ISO 19011 and the agreed audit plan, with findings documented throughout the execution phase.
STEP 5
Reporting
A structured audit report is prepared and delivered to the manufacturer, covering all findings, observations, and non-conformities identified during the audit, with recommended corrective actions for each identified finding.
STEP 6
Follow-up
EUMEDIQ conducts a follow-up review of the corrective actions implemented by the manufacturer in response to audit findings, verifying the effectiveness of each action and formally closing out all open non-conformities.
OUR EXPERTISE
Certified lead auditors with core competence in software, eHealth, and medical device management systems
EUMEDIQ's auditors hold lead auditor certification for management systems in the MedTech industry according to ISO 13485, MDSAP, and ISO 27001. All auditors undergo regular professional development to ensure current and upcoming regulatory requirements are consistently reflected in every audit engagement.
Our core auditing competence extends to software and eHealth, covering medical device software and apps, combination products, electrical safety-related devices, and plastic injection moulding processes, providing manufacturers with specialist audit expertise across a broad range of device types and technologies.
Management system audits
Auditing services for quality management and information security management systems in accordance with ISO 13485, MDSAP, ISO 27001, and US QMSR (former 21CFR Part 820).
MANAGEMENT SYSTEMS
Gap assessments
MDR, IVDR, HIPAA, and NIST 2 Structured gap assessments providing a documented baseline of the manufacturer's current compliance position against applicable regulatory requirements.
REGULATORY COMPLIANCE
Supplier audits, internal audit programmes, and mock audits
Audit services to medical device-related standards and regulations, covering supplier qualification, internal audit programme support, and pre-certification mock audits.
AUDIT SERVICES