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Medical Device Translation Services
Medical Device Translation Services ā Overview
Leveraging technical writing expertise and fluency in over 100 global languages, Pharma Wizard offers specialized medical device translation services through a team of seasoned medical language translators and editors. Our experts ensure accurate, context-appropriate translations that align with the targeted regional language. Supported by a robust Quality Management System (QMS) compliant with ISO 17100:2015 and ISO 9001:2008 standards, Pharma Wizard guarantees high-quality, error-free translations. Our services encompass both general and scientific translation needs for medical devices.
Pharma Wizardās Medical Device Regulatory Intelligence framework integrates the latest global regulations and Health Authority (HA) positions across diverse regulatory topics, delivering precise, market-specific insights. Designed to support manufacturers in achieving and maintaining market access, this framework ensures they remain informed in an ever-evolving regulatory environment.
With a global network of regulatory experts, Pharma Wizard provides comprehensive intelligence on HA requirements and regional market conditions. Our offerings include tailored ad-hoc Regulatory Intelligence reports, periodic global update reports, and targeted newslettersācustomized by region and device typeāto meet the specific needs of each organization.
Medical Device Translation Services
- Expertise
- Advantages
- Translation of Instructions for Use (IFUs).
- Medical device operation, maintenance and installation manuals, and instruction and user guides.
- Descriptions of the manufacturing process.
- Product catalogues.
- Clinical training materials.
- Package inserts and labels.
- Brochures and web content.
- Regulatory compliance documents.
- Informed consent forms for clinical trials.
- Validated back translation and sworn translations in certain countries.
- Localization of medical device software and translation of resource files.
- Software application interfaces and documentation.
- Patents for medical and surgical devices.
- General and scientific translation.
- Translation of agency guidelines published in the local language.
- Dedicated local affiliates in multiple countries across the world.
- Cost-effective and timely delivery.
- Expert translators and language specialists to simplify complex technical jargons.
- A qualified team of experts with hands-on experience across all categories of medical devices.
- A customized approach based on the complexity, class, and type of the product involved.
- Services tailored to meet region-specific Regulatory complexities.
- A strong relationship with local agencies of various countries.
- A structured approach to ensure quick market access.