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Build a quality management system that works in practice and stands up to review.
ISO 13485 Compliance
ISO 13485 is the globally recognized standard for medical device quality management that was published on February 25, 2016. The primary focus of ISO 13485 was on quality management systems which is now used as a framework by all medical device regulatory programs including MDSAP.
What is the ISO 13485 standard?
ISO 13485:2016 specifies quality management system requirements for organizations involved in the medical device lifecycle. It supports consistent processes that meet customer and applicable regulatory requirements.
Your QMS should reflect your devices, activities, sites and outsourced processes. Certification assesses the defined QMS scope; product market authorization is a separate requirement.
When should you review your QMS?
A review can help when:
⦿ You are preparing for your first certification audit.
⦿ Procedures exist, but implementation records are incomplete.
⦿ A surveillance or recertification audit is approaching.
⦿ Findings recur despite corrective actions.
⦿ Products, suppliers, sites or responsibilities have changed.
Our ISO 13485 consulting services
Gap analysis and pre-assessment audits
Review procedures, records and implementation against applicable requirements.
Deliverables: Gap assessment and prioritized action plan.
QMS implementation
Establish or improve document control, training, supplier controls, design and development, production, complaints and CAPA processes.
Deliverables: Agreed procedures, forms and implementation tracker.
ISO 13485 certification readiness
Assess your QMS scope, process implementation and supporting evidence before independent assessment.
Deliverables: Readiness review, evidence-gap tracker and audit preparation plan.
Surveillance and recertification audit readiness
Review QMS changes, previous findings, corrective actions and current records before your next audit.
Deliverables: Targeted assessment and action plan.
Internal audits and ongoing support
Our internal audit services help assess implementation and identify gaps. For continuing needs, our quality management system support helps maintain documents, records and follow-up activities.
Deliverables: Audit reports or an agreed review schedule and action tracker.
Services and deliverables are defined in the proposal. Independent certification bodies perform certification audits and issue certificates.
Our compliance assessment process
⦿ Define your scope: Discuss your devices, activities, sites and audit objectives to agree on the review scope and required documents.
⦿ Review processes and evidence: Examine selected procedures and completed records to identify documentation and implementation gaps.
⦿ Prioritize actions: Set clear priorities, responsibilities and implementation steps based on the findings.
⦿ Support improvements: Update agreed documents and guide implementation within the project scope.
⦿ Recheck readiness: Review completed actions and supporting evidence to identify any remaining gaps.
Reviews can be delivered remotely, with onsite activities considered where process or facility observation is needed.
Have an audit approaching?
ISO 13485 and FDA QMSR
FDA’s Quality Management System Regulation became effective on February 2, 2026, incorporating ISO 13485:2016 by reference alongside additional FDA requirements.
ISO 13485 certification alone does not establish FDA compliance or exempt a manufacturer from inspection. Applicable reviews should address risk-based decisions and supporting records, including internal audit, supplier audit and management review reports.
See the FDA QMSR FAQs for further guidance.
Why Elexes?
- Connected evidence: Review whether procedures, completed records and follow-up actions align.
- Practical scope: Focus on your devices, operations and current QMS maturity.
- Clear priorities: Give process owners defined actions and evidence expectations.
Explore our guide to medical device complaint file audit readiness.
Check your QMS scope, documents, training, design, suppliers, production, complaints, CAPA and audit records.
Use the checklist to identify missing evidence and prioritize follow-up actions.
FAQs
Frequently Asked Questions!
An ISO 13485 certification consultant helps assess gaps, improve QMS processes and prepare for independent assessment. The certification body conducts the certification audit and makes the certification decision.
Yes. We review current procedures and records to identify what can be retained, updated or strengthened.
Timing depends on your QMS maturity, scope, available evidence and implementation needs. We define the work plan after understanding these factors.
Fees depend on the review scope, sites, activities and support required. Deliverables, timing and fees are defined in the proposal.
A Trusted Team of Consultants
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Local Language
Auditor
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Why Choose Elexes?
Expertise
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
Local Regulatory Certification
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
Confidentiality
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
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