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Ensuring quality and safety in the medical device sector

Published on 27/09/2024

A crucial role in healthcare

The medical device sector is essential for providing safe and effective healthcare. These devices encompass a wide range of equipment and services, designed to diagnose, prevent, monitor, treat, mitigate, compensate, modify, or replace in cases of diseases or injuries.

Classification of medical devices

Medical devices are classified according to their risk level, which determines the regulatory requirements that ensure their safety and effectiveness:

  • Class I: low risk (e.g., reusable surgical instruments)
  • Class II: moderate risk (e.g., syringes, diagnostic tests)  
  • Class III: high risk (e.g., cardiac implants)

This classification is essential when defining the control and management measures necessary to protect patients.

ISO 13485 standard: quality management framework

The ISO 13485 standard is widely recognised for ensuring compliance with best industry practices and patient safety. It specifies the requirements of a quality management system applicable to medical devices, covering all aspects of the life cycle, from design to commercialisation.

Key aspects of the ISO 13485 standard

  1. Regulatory compliance: adherence to local and international regulations.
  2. Manufacturing process management: rigorous control for consistent quality.
  3. Risk assessment: identification, evaluation, and control of risks throughout the product life cycle.
  4. Surveillance systems: rapid detection and correction of after-market issues.
  5. Traceability: tracking each product to facilitate recall in case of faults.

The ISO 13485 standard applies to all stakeholders in the sector, including manufacturers, designers, distributors, and subcontractors, to ensure a consistent and reliable production chain.

Importance of accurate translations in the medical field

The accuracy of translations is crucial in the medical field, where errors can have serious consequences for patient safety and health. Medical translations must be precise and adhere to the specific terminology of the field.

ISO 17100 standard: quality assurance for medical translations

The ISO 17100 standard sets minimum requirements for resource management and translation quality, replacing the EN-15038 standard of 2006.

Requirements for translators and translation processes

  • High professionalism: professional translators must meet at least one of the following three conditions:
  1. hold a degree in translation or a relevant field,
  2. hold an equivalent degree in another field plus at least two years of professional translation experience,
  3. have at least five years of demonstrable professional translation experience.
  • Bilingual review: this ensures the accuracy and reliability of translations.

The translation process according to ISO 17100

  1. Project management: feasibility assessment, quote creation, and contract establishment.
  2. Translation: initial translation, review, and correction to ensure accuracy and consistency.
  3. Post-production management: consideration of modifications and customer feedback to continuously improve quality.

Advantages of an ISO 17100 certified translation agency

  1. High-quality translations: use of specialised translators and rigorous procedures.
  2. Detailed reviews: guaranteed by linguists and medical experts.
  3. Safety and reliability: ensuring compliance with standards to guarantee high-quality products and services.

Conclusion

Quality and safety are paramount in the medical sector. The ISO 13485 and ISO 17100 standards establish rigorous criteria to ensure the reliability of medical device translation. By complying with these standards, companies and translation agencies that work with medical translators contribute to patient safety and the improvement of healthcare quality.

Virginia Pacheco's picture
Virginia Pacheco

Blog writer and Community Manager interested in multiculturality and linguistic diversity. From her native Venezuela, she has travelled and lived for many years in France, Germany, Cameroon and Spain, passing on her passion for writing and her intercultural experiences.

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