ISO 13485 certification: Quality management systems for medical devices
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EN ISO 13485 defines international requirements for quality management systems for medical devices. More than just a document inspection: during the on-site audit, our experienced auditors reveal how your quality management system is actually implemented - precisely, neutrally and transparently.
What is ISO 13485?
ISO 13485 is the international standard for quality management systems in the medical device sector. It is aimed at all organizations along the value chain – from development to manufacturing to storage and distribution of medical devices. The standard forms a central basis for the approval of medical devices in numerous markets worldwide, including Europe with the CE marking.
MDSAP in the international context
In Australia, Brazil, Canada, Japan, and the USA, the ISO 13485 certification is supplemented by the MDSAP (Medical Device Single Audit Program), which consolidates multiple country-specific requirements into a single audit.
The most important differences to the ISO 9001 certification:
- Focus on the safety and performance of medical devices instead of general customer orientation
- Risk management as a central, continuous element in quality management
- Stricter requirements for the validation and verification of processes
- Significantly more extensive documentation requirements for medical device manufacturers
What requirements does ISO 13485 place on organizations?
The ISO 13485 certification is based on five essential pillars of quality management:
- A fully documented quality management system
- Clearly defined management responsibilities
- Systematic resource management
- Continuous control of product realization
- Continuous measurement, analysis, and improvement
These requirements for quality management systems apply equally to medical device manufacturers, suppliers, service providers, and software developers—everywhere medical products are created or processed.
What are the benefits of certification according to ISO 13485?
- Market access: Simplified entry into international markets for your medical products, especially in Europe, the USA, and Asia, where the standard is recognized as a quality benchmark.
- Legal certainty: Proof of compliance with regulatory requirements for medical devices and thus an improved legal position towards authorities and in case of damage.
- Customer loyalty: Increasing the trust of customers, patients, and healthcare facilities through demonstrable quality orientation and standardized processes.
- Process optimization: Structured improvement of internal processes, reduction of error risks, and efficiency enhancement throughout the entire product lifecycle.
Which organizations need ISO 13485 certification?
The ISO 13485 certification is particularly relevant for:
- Medical device manufacturers: From imaging technologies and implants to surgical instruments – certification is often essential for all medical device manufacturers.
- Suppliers: Companies that provide components for medical devices are increasingly required to obtain certification to remain competitive in the supply chain.
- Medical technology service providers: Service providers for the installation, maintenance, and repair of medical technology equipment benefit from structured process management.
- Software developers in the medical field: For software classified as a medical device or used in medical applications, ISO 13485 serves as a crucial quality certification.
- Manufacturers and distributors: Organizations that assemble, sterilize, package, or distribute medical devices increasingly require certification.
What the certification does not provide
The standard does not assess individual products and does not replace product certification or approval. Instead, it confirms that your management system has established the minimum process requirements for developing, manufacturing, and distributing medical devices. The ISO 13485 quality management system provides an excellent foundation for producing high-quality medical devices.
Your benefits with Berlin Cert for ISO 13485 certification
Our auditors have industry-specific expertise in the medical device sector and conduct assessments with precision and neutrality. We place great emphasis on on-site audits, as they reveal how your quality management system for medical devices is actually implemented and where potential improvements can be made.