ISO 13485 is the international quality management standard for medical devices — a baseline requirement for FDA clearance, CE Mark and registration with the Israeli Ministry of Health. Without ISO 13485 there's no access to regulated markets. CBE has been guiding medical-device manufacturers for 30 years — with 100% audit success and over 4,000 satisfied clients.
CBE specializes in guiding and certifying organizations for the ISO 13485 standard, tailoring the management system to the organization's needs.
Quick facts – ISO 13485
Goal
Dedicated quality management for the medical-device lifecycle
Who needs it
Manufacturers, importers and distributors of medical devices
Importance in Israel
Ministry of Health requirement and device registration
Complements
CE Mark, FDA 510(k), HIPAA, ISO 27799
CBE – success rate
100% – hundreds of certified clients
ISO 13485 is the international standard for quality management dedicated to the medical-device industry. Unlike ISO 9001, it emphasizes product safety throughout the device's lifecycle — from development to post-market management.
The standard is recognized by the FDA, EMA, Health Canada, TGA and the Israeli Ministry of Health. In practice, without ISO 13485 a medical device cannot be registered in most of the world's markets.
CBE doesn't just guide you to certification — we build a complete QMS framework that also supports CE Mark, FDA and local registration. Because in the medical world, one standard alone isn't enough.
Managing safety risks throughout the medical device's lifecycle.
Documenting design requirements and the product record across the device's lifecycle — required by FDA and CE.
Reporting processes, recall management and correcting field safety events.
Qualifying critical suppliers, quality agreements and periodic audits across the supply chain.
ISO 13485 is a baseline condition for registering a medical device in any regulated market — FDA, CE, Ministry of Health.
To sector pageMedical-device importers are increasingly required to hold ISO 13485 to meet registration and local-import requirements.
Medical software (SaMD) enters medical-device regulation. ISO 13485 is a condition for FDA SaMD and MDR clearance.
To sector pageIVD devices are subject to IVDR (EU) and FDA 21 CFR Part 820 — both require ISO 13485 as a basis.
Manufacturers supplying components to medical-device makers are sometimes required to hold ISO 13485 as a supplier requirement.
To sector pageClinical research organizations and testing labs providing services to manufacturers are required to hold ISO 13485 as certified assurance.
Without ISO 13485 — no access to FDA, CE, EMA and Ministry of Health markets
A certified QMS protects the manufacturer in safety and field-event claims
ISO 13485 significantly shortens the FDA and CE Mark approval process
Recognized in 100+ countries — one certification opens most markets
Defining the organization's needs, stakeholders and the scope of the quality management system.
Process planning and control, managing customer requirements, external providers and output control.
Management commitment, quality policy and defining roles and responsibilities.
Measurement, analysis, internal audit and management review.
Risk and opportunity management, quality objectives and plans to achieve them.
Managing non-conformities, corrective actions and continuous improvement of the system.
Resources, employee competence, internal communication and documentation.
CBE performs a full Gap Analysis and builds a work plan tailored to your organization.
Medical-device manufacturers are usually required to frame a broader regulatory picture beyond ISO 13485
CBE accompanies you at every stage — from Gap Analysis to regulatory approval and annual audits
Mapping the current state, target market and regulatory path (FDA/CE/Israel)
Procedures, SOPs, DHF/DMR, Design Controls and regulatory documentation
Team training, validation/qualification, CAPA and Complaint Handling processes
Preparing for the certification body's audit — BSI, TÜV, SGS and more
Guidance through the official audit and annual renewals
30 years, hundreds of clients, 100% success — here's what sets us apart
Committed to success! No client has ever failed a certification audit. Not certified — you don't pay!
We adapt the schedule to your deadline — tender, supplier, client.
Procedures and documentation — we write them. Not generic templates — tailored to your organization.
ISO 13485 is the foundation. CBE also guides you to CE Mark, FDA, HIPAA, ISO 27799 and more — under one roof.
We don't disappear after the certificate. Annual audits, standard updates, organizational changes.
From startup to corporation — experience with every organization type in every field.
ISO 13485 is the foundation — but entering FDA, CE and Ministry of Health markets requires additional layers. CBE manages your entire regulatory journey under one roof.
About CBE's GRC frameworkCBE specializes in guiding and certifying organizations for the ISO 13485 standard. The service is provided by CBE's experts, with 30 years of experience in ISO standards, over 4,000 satisfied clients and 100% success in audits.
Tell us about your product and target market — we'll come back with a tailored regulatory path