ISO 17100 Certified Technical Translation Services for Successful Medical Device Audits
ISO 17100 certified translation services are essential for medical device manufacturers facing international audits. At Tilde, our ISO 17100 certified translation services guarantee accuracy, compliance, and peace of mind for documentation in regulated industries.
In the highly regulated medical device industry, compliance with international standards during audits is crucial for maintaining market access and company reputation. A well-known manufacturing company preparing for a critical international audit found itself facing the challenge of delivering precise, reliable translations of their key technical documents under verifiable standards.
Tilde’s ISO 9001 and ISO 17100 certifications and its specialized translation team provided the solution that enabled a successful audit outcome, paving the way for continued trust and business growth.
The Client’s Challenge: Accuracy and Compliance Under Scrutiny
The company’s medical device manufacturing plant in Costa Rica was subject to an international regulatory audit, which required submitting a full set of technical documentation translated into English and Spanish. Crucially, the translation process had to be transparent, traceable, and certified according to ISO 17100 to satisfy the auditor’s stringent requirements.
Failing to meet these translation standards could have led to delays or negative audit results, impacting product registrations and market access. The company sought a translation partner experienced not only in medical device terminology but also in managing the compliance and traceability demanded by such audits.
Tilde’s Tailored Solution: Expertise Meets Certified Processes
Recognizing the critical nature of the project, Tilde mobilized a dedicated team specialized in technical translation within regulated sectors:
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A specialized technical translator with proven knowledge in health and regulated manufacturing industries
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An independent reviewer, fulfilling ISO 17100 certification’s requirement for bilingual review and quality assurance
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A project manager serving as the single point of contact, ensuring smooth communication and streamlined workflows
Tilde’s certified workflow included rigorous linguistic quality controls and version traceability measures, documenting every stage for audit transparency. Deadlines were consistently met with timely and accurate deliveries, providing the client with auditable proof of compliance.
Results That Speak for Themselves
Thanks to Tilde’s thorough approach, the company passed the audit with no observations related to documentation or language issues. The client expressed confidence and peace of mind, knowing they had partnered with a supplier backed by regulatory expertise and a proven track record.
Since then, Tilde has become a preferred service provider for the company’s ongoing, demanding translation needs, strengthening its strategic position in the medical sector.
Why Choose Tilde for Regulated Sector Translations?
Tilde stands out as Central America’s first translation company certified under both ISO 9001 (quality management) and ISO 17100 (translation services). The combination of these certifications reflects Tilde’s commitment to:
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Delivering translations that strictly adhere to international quality and regulatory standards
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Employing specialized professionals with sector-specific expertise
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Managing projects through a centralized point of contact, ensuring traceability and client satisfaction
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Providing confidentiality safeguards aligned with contractual and technological requirements
This unique positioning makes Tilde the trusted partner for companies that cannot afford to entrust critical documentation to unqualified providers.
The Importance of Certification for Your Business
Translating technical documents in medical device manufacturing is not just about language accuracy—it’s about minimizing risks and maintaining regulatory compliance. Certification under ISO 17100 means that your translation partner follows globally recognized protocols covering:
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Translator qualifications and experience verification
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Rigorous review and revision steps with independent bilingual reviewers
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Project management that includes documented traceability and client communication
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Continuous quality improvement aligned with ISO 9001 standards
Choosing an uncertified provider can expose your business to costly delays, regulatory hurdles, or even legal liabilities.
Partner with Tilde: Your Assurance of Quality and Compliance
At Tilde, we understand the pressure regulated sector companies face during audits and compliance verifications. Our ISO-certified processes and industry expertise provide our clients with the confidence that their technical translations meet or exceed all regulatory expectations.
If your company operates in a regulated industry and faces challenges with translation compliance and quality, contact Tilde today for a personalized consultation and custom quote.
