Implementation of QA proceses aligned with EU MDR & IVDR regulations
Industry/Sector: Life Sciences & pharmeceuticals
The implementation of the European Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) has raised the bar significantly for translation and localisation providers.
Ensuring compliance with these stringent requirements can be daunting, yet SMARTIDIOM has successfully navigated this challenge through a structured and rigorous approach to quality assurance (QA).
The challenge
A major European medical device manufacturer approached SMARTIDIOM needing to ensure complete compliance with MDR and IVDR regulations for their multilingual product documentation.
With the regulatory audits intensifying, the client required absolute accuracy, consistency, and traceability across translations of user manuals, labelling, patient information leaflets, and regulatory submissions.
SMARTIDIOM's strategy
1- Specialised translator training:
SMARTIDIOM developed and delivered specialized training for its medical translators, focusing on MDR/IVDR terminology, guidelines, and compliance requirements. Translators underwent certification to ensure full understanding of the nuances of medical device documentation.
2 - Dual review process:
Implemented a mandatory two-tier review for every translation project, including linguistic review and regulatory compliance verification. This ensured alignment with both linguistic quality standards and MDR/IVDR-specific criteria.
3 - Strict QA checkpoints:
Established rigorous checkpoints within the translation workflow, leveraging ISO 17100 guidelines. These checkpoints verified adherence to regulatory language, accuracy of medical terminology, formatting consistency, and documentation traceability.
4 - Dual review process:
Integrated specialized QA software, such as Xbench and Verifika, to detect inconsistencies, numerical errors, and deviations from approved terminology.
5 - Continuous feedback loop:
Maintained regular feedback sessions between translators, reviewers, and client compliance teams, allowing for continuous refinement of terminology databases, glossaries, and style guides, resulting in ongoing improvements.
Challenges overcome
Implementing such a robust QA system was not without its hurdles:
Here’s how it works:
- Initial training and certification: Ensuring all linguists met the high standards required significant investment in training and resources.
- Use paid campaigns to bring in traffic, then convert through nurturing via organic posts
- Workflow complexity: Adding dual reviews and multiple checkpoints required refining internal processes to avoid bottlenecks and ensure timely delivery.
- Client collaboration: Establishing clear communication channels with the client’s compliance team to receive and integrate feedback effectively was crucial.
KPIs achieved
The structured approach yielded impressive results:
Zero critical findings: During subsequent regulatory audits, the client experienced zero critical findings related to language and documentation compliance.
Reduction in QA revisions: Overall revisions and corrections after initial QA dropped by 30%, thanks to the stringent processes and advanced tools.
Enhanced client confidence: The client reported significantly increased trust in SMARTIDIOM, leading to expanded collaboration on additional multilingual documentation projects.
Conclusion
This case exemplifies how SMARTIDIOM leverages specialized knowledge, rigorous training, and strategic QA practices to successfully meet and exceed stringent regulatory standards.
By aligning its processes meticulously with EU MDR and IVDR, SMARTIDIOM ensures consistent, accurate, and compliant multilingual documentation, becoming a trusted partner for clients operating in highly regulated sectors.
What this client says
“Working with SMARTIDIOM transformed our compliance processes. Their attention to detail, rigorous training, and proactive QA approach gave us confidence and peace of mind during audits. Their expertise in MDR and IVDR compliance was instrumental in our international growth strategy”.
Compliance Manager, European Medical Device Manufacturer