ISO 13485 - Medical Devices
The international quality standard for the design, production, and distribution of medical devices
ISO 13485:2016 is the internationally recognized standard for Quality Management Systems in the design and manufacture of medical devices. It ensures medical products meet safety and efficacy requirements.
The standard covers clauses 4-8 with specific requirements for system documentation, management responsibility, resource management, product realization, and performance monitoring. It places particular emphasis on risk management (CAPA), traceability, software validation, and supplier controls.
In Greece and the EU, ISO 13485 certification is an essential prerequisite for CE marking of medical devices under the MDR Regulation (EU) 2017/745. Manufacturers must demonstrate they meet every requirement of the standard.
Certification is valid for 3 years and is verified through audits by authorized certification bodies.
Who is this for
ISO 13485 is aimed at medical device manufacturers, importers and distributors of medical devices, medical equipment design companies, medical device component suppliers, sterilization companies, and any organization in the medical device supply chain.
Key Benefits
CE Marking & Market Access
Essential prerequisite for CE marking under MDR Regulation (EU) 2017/745 and European market access.
Regulatory Compliance
Compliance with regulatory requirements of EU, FDA, and other international regulatory authorities.
Patient Safety
Ensuring safety and efficacy of medical products through systematic risk management.
Product Traceability
Full traceability from raw materials to end user for every medical product.
International Recognition
Accepted in 60+ countries as a basis for regulatory compliance for medical devices.
ISO 13485 Certification Process
Initial Assessment
Assessment of existing QMS, medical device classification, and identification of regulatory requirements.
Gap Analysis
Identification of gaps from clauses 4-8 requirements, risk assessment, and CAPA planning.
Staff Training
Training on GMP, risk management, CAPA, traceability, and MDR regulatory requirements.
Documentation Development
Drafting quality manual, technical files, design control procedures, CAPA and recall procedures.
Certification
Support during certification audit by Notified Body for CE marking.
ISO 13485 FAQ
Certification is not technically mandatory, but in practice it is a prerequisite for CE marking in the EU under MDR Regulation 2017/745. Without it, access to the European market is not feasible.
ISO 13485 is based on ISO 9001 but includes specific requirements for medical products: risk management, traceability, design control, software validation, and CAPA. It does not require "continual improvement" but "maintaining effectiveness".
Cost depends on product complexity and number of facilities. For SMEs, it starts from EUR 10,000. Notified Body audit costs an additional EUR 5,000-15,000.
ISO 13485 implementation and certification typically takes 6-12 months, depending on the risk class of medical products and existing organization.
A Notified Body is an EU-authorized conformity assessment body. It evaluates the manufacturer's QMS and technical files for CE marking.
Certify your medical devices
Contact us for a free ISO 13485 readiness and CE marking assessment.