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ISO 13485 Certificate

ISO 13485 certification accredits that our manufacturing processes comply with international quality requirements applicable to medical devices. It guarantees traceability, safety and control at every stage of production, offering maximum confidence to our customers and the medical sector.

What is the ISO 13485 standard?

Safety and quality are fundamental aspects within the medical device industry. Companies in the sector are required to demonstrate a high level of control and excellence in all their processes, ensuring that each product meets very strict requirements. To this end, there is the ISO 13485 standard, an internationally recognised standard that defines how a quality management system specifically adapted to medical devices should be structured.

This standard has been widely used and validated in the sector. Having this certification means that the organisation has the technology, equipment and personnel necessary to manufacture reliable, safe and high-quality products. It also confirms that internal processes are managed appropriately, following practices that guarantee efficiency, safety and traceability at every stage.

The certification assesses whether the management system in place is functioning correctly and meets all the established requirements. Obtaining it means having passed a comprehensive assessment and demonstrating the real and effective implementation of a robust quality system.

The current revision, published in March 2016, introduced significant improvements. These include a more risk-based approach, greater clarity on training and management responsibilities, more precise alignment of design and development requirements, and increased control of suppliers and subcontractors, ensuring greater consistency and reliability throughout the supply chain.

What are the benefits of ISO 13485?

Improved credibility and image for the company.

Increased customer satisfaction.

Improved system and processes in general.

Improved decision-making.

Creation of a culture of continuous improvement.

Improved employee commitment.

Clarification of management responsibilities.

Improved training.

Improved facilities.

Improved design and development control.

Improved supplier controls.

So, basically, when a manufacturer has 13485, it guarantees that it has clearly defined management, clean spaces, streamlined procedures and accountability.

Three specific areas that are truly enhanced

Traceability

Traceability is the ability to track something. It is also interpreted, in some cases, as the ability to verify the history or previous record, the place or location, or the application of the product through registered and documented identification.

Process validation

Process validation contributes significantly to ensuring the quality of the medical device. Validation means verifying that the expected results and objectives have been achieved in those stages where verification cannot be performed, in the case of processes affected by computer programmes in production, and in sterilisation and sterile barrier systems.

Risk management

Risk management involves identifying, understanding, controlling and preventing failures that could lead to hazards when people use medical devices. It is a key aspect of ensuring device usability, safety and regulatory compliance.

Who requires ISO 13485?

Certified organisations include those involved in the life cycle of medical devices. Organisations that may be involved in the development, design, storage, production or installation of medical devices include:

Medical device manufacturers.

Medical device (software) developers.

Manufacturers of medical device parts or components.

Providers of medical device installation, maintenance or servicing services.

ISO 13485 requirements

Quality management system

QMS means that the organisation must meet all the expectations and requirements of the Quality Management System. The organisation must also create and maintain a Quality Manual and technical documentation that forms part of the medical device file.

Management responsibility

This involves senior management being involved in the continuous review of the system to ensure that customers are satisfied. There must be a commitment to maintaining and implementing a Quality Management System.

Resource management

This involves the need to control all of the organisation’s resources, including buildings, infrastructure, human resources and the working environment.

Product realisation

This covers all aspects necessary for the planning and creation of medical devices. It includes requirements for planning, design, purchasing, device creation and control of the equipment used to monitor and measure the product.

Measurement, analysis and improvement

This requires the organisation to ensure that it can monitor its quality management system and assess whether it is working well or not. It can be seen as a way of ensuring that the Quality Management System remains effective.

Additional requirements not required by other certifications such as ISO 9001

Specific requirements for the working environment

Contamination control requirements

Specific production requirements for product cleanliness

Specific production requirements for sterile medical devices

ISO 13485 and its application in plastic injection moulding

Plastic medical devices have become a necessary and vital component of the modern healthcare system. Product durability, sterilisation and biocompatibility are important factors that must be met in accordance with regulatory and safety requirements. To ensure safety, polymers for medical devices are mostly manufactured from thermoplastic materials.

Thermoplastics are synthetic polymers that can be remoulded and reheated several times without causing any irreversible degradation. They can therefore be recycled and reused.

Polycarbonates are best known for their impact and temperature resistance properties, and their applications include plastic lenses in spectacles, automotive components, protective equipment and medical devices.

Sterilisable medical devices must be made of polypropylene.

Polyethylene is a versatile and durable thermoplastic that is often used in medical implants. It can withstand harsh cleaning agents and does not fade or harbour dangerous bacteria.

Biocompatibility and sterilisation for medical devices

Biocompatibility refers to the ability of a material to respond appropriately to the host in a specific situation. Sterilisation refers to any process that eliminates, kills or deactivates all forms of life and other biological agents present on a specific surface, object or fluid.

Sterilisation and biocompatibility are essential for new medical devices. Depending on the materials and components used, the potentially appropriate sterilisation method and validation experiments must be selected.

Biocompatibilidad y esterilización de dispositivos médicos

Appropriate selection of material characteristics for medical device design

Plastic injection moulds for medical use primarily require operational quality controls. It is important to make appropriate design considerations when selecting a plastic for medical devices or components.

In the injection moulding process, material selection, production process and part geometry are interrelated.

The following parameters must be considered:

Temperature

Chemical contact and resistance

Stresses applied during use

Transparency/opacity

Colour used to aid identification

Aesthetics

Water absorption

Lubricity and wear resistance

Sterilisation resistance and hardness

Considerations for medical device manufacturing:

Safety and quality are non-negotiable in the medical device industry. Organisations are increasingly required to implement an appropriate quality management system and are expected to demonstrate their quality management processes, thereby ensuring best practices in everything they do.

The internationally agreed ISO 13485 standard sets out all the appropriate requirements for a quality management system specific to the medical device industry.

ISO certification and compliance

The ISO 13485 standard regulates processes and products in the healthcare sector and is mandatory for all facilities that produce medical components. In addition, biocompatibility standards, such as ISO 10993, may also be required, depending on the risk classification of the device.

Material properties

The specific physical properties of the materials chosen for medical components and devices must be taken into account.

These include:

Capacidad de resistencia a los contaminantes

Resistance to contaminants

To prevent harm to the people with whom they interact, materials must be resistant to contaminants and sterilisable.

Ability to withstand extreme environments

Exposed to environmental factors such as heat, liquids, corrosives, vibrations and other movements, bioimplants must be able to withstand harsh environments.

Material durability

The material must offer the necessary resistance to breakage and tearing in the medical field.

Comparison between ISO9001 and ISO13485

The ISO 13485 standard is similar to the better-known ISO 9001, except that it is more specific to medical devices and related parts.

All stages of product realisation, such as product development, control documentation, risk management, traceability, complaint management, labelling and manufacturing, are covered by ISO 13485.

Furthermore, this certification is a requirement for CE marking for sale in EU markets. The FDA also recognises ISO 13485 as an adequate safety standard for medical devices.

Main additional requirements of ISO 13485 compared to ISO 9001

Risk management required at all stages of medical device manufacturing.

Prevention of contamination.

Effective monitoring of customer requirements, rather than mere subjective measures of customer satisfaction.

Maintenance of the ongoing suitability and effectiveness of the quality management system, rather than seeking continuous improvement.

Validation of the production process.

ISO 13485 is the most suitable SGQ for medical devices.

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