ISO 13485 Consulting

We assist you with your quality management system

Our ISO 13485 consulting services help you implement and maintain an efficient quality management system for medical devices, ensuring compliance with international standards.

Quality management according to ISO 13485

At CMC, we can help you establish your quality management system according to ISO 13485:2016.

This is particularly important as new regulations with stricter requirements have come into effect. Our certified auditors will assist you in enhancing the quality of your company.

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ISO 13485

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Frequently asked questions about ISO 13485

ISO 13485 is a quality management standard designed to ensure that medical devices are safe and effective. It is crucial because it helps you comply with international regulations and access global markets.

If your company designs, manufactures, distributes or maintains medical devices, probably yes. In many markets, such as the European Union or the United States, this certification is a requirement to sell or distribute medical products.

Implementing ISO 13485 gives you access to wider markets, improves the quality of your products, reduces risks, and increases the confidence of your customers and regulatory authorities in your processes.

It depends on the size and complexity of your company, as well as how developed your current quality management system is. It can take anywhere from several months to a year or more.

It requires you to rigorously document and manage every step of the design process to ensure that the product meets safety and functionality requirements from the planning stage through to production and use.

At CMC, we can help you establish your quality management system according to ISO 13485:2016

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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