Packaging solutions for demanding industries

Satatuote cleanroom process has achieved ISO 13485 - Medical device certification.

ISO 13485 is a standard specifically designed for the medical device industry. Its certification assures customers that we adhere to rigorous quality management processes. This translates to a higher level of confidence in the quality and safety of the solutions and services our customers are requesting from us.

Satatuote´ s Quality and  Compliance Manager Tiina Leino explains achieving ISO 13485 certification is a significant step for us towards delivering a best-in-class customer experience in the medical device industry.

Leino continues how achieving ISO 13485 certification holds significant implication to continue building strategic partnerships in the medical device industry. ISO 13485 aligns with regulatory requirements in the medical device sector. Customers benefit from knowing that our organization complies with these standards, reducing the risk of regulatory issues.

Furthermore, the standard emphasizes standardized processes throughout the product lifecycle. Our customers can expect consistent and reliable products, as we are following a systematic approach to design, development, production, and post-market processes.

Leino knows that risk reduction is important and always comes up in discussions with quality departments in medical device customers. ISO 13485 places a strong emphasis on risk management. By adhering to this standard, we need to identify and address potential risks associated with our products to our customers medical devices. Our customers benefit from products that have undergone thorough risk assessment, minimizing the likelihood of unexpected issues.

ISO 13485 also encourages to incorporate customer feedback into their processes. This means we are attentive to customer needs and concerns, leading to products and services that are more tailored to meet customer expectations.

In summary ISO 13485 certification not only ensures compliance with industry standards but also serves as a powerful tool to build and maintain a best-in-class customer experience. ISO 13485 certification provides customers with the assurance that we are dedicated to delivering high-quality, compliant, and safe product for our medical device customers. It establishes a foundation for trust, reliability, and customer satisfaction, contributing to a positive and enduring relationship with our valued customers.