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Comate is ISO 13485 certified

24 November 2021

Safety and quality are non-negotiable in the health industry. With Comate, we deliver high-quality products to our clients. Our ISO 13485:2016 certification assures that we work according to the latest standards and regulations and that our quality management system meets or exceeds all requirements.

There are a few sectors where innovation can have such a profound impact on people’s lives as in the Healthcare sector. It is also one of the most regulated sectors where patients’ lives are literally at stake, and patient and caregiver safety are absolute priorities. Medical device companies need to ensure that their new products will be in full regulatory compliance prior to hitting the market.

Comate implemented a quality management system that is compliant with the ISO 13485:2016 standard. This means we have processes in place that indicate possible risks towards patient safety and that take the necessary measures to reduce these risks as much as possible. This quality accreditation ensures that our products are designed and delivered to the highest standards as part of a fully controlled process.

The safety and effectiveness of a product is extremely important. Within the health sector, this is non-negotiable since it can be a matter of life and death. Quality and risk control throughout all stages of product development is therefore a must.

What is ISO 13485?

Within the medical device industry, standards are defined to ensure quality and reliability throughout the entire product life cycle, including product design. The ISO 13485 standard defines a broad range of requirements on quality management systems (QMS) for medical devices and equipment.

When a company is ISO 13485-certified, it means that they implemented a quality management system and successfully met all of the requirements of ISO 13485. The company must comply with a list of documentation, design and development, traceability, testing and other production requirements. The certification shows that the processes used in the company are appropriate and effective while emphasizing the safety and efficacy of medical devices. It also guarantees that everyone working on a medical project is fully trained and competent to execute his job to the highest standards.

Innovation in Health care

Medical product development requires expertise and specific knowledge (about ISO 13485, MDR, …). We offer a complete package, from product development to innovation management and QARA

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