With an ever increasing need for globalized documentation, including related information to support regulatory and marketing activities, medical device companies face an ongoing challenge to deliver more content, more quickly, into more languages.
Whether you manage large-volume user documentation or many smaller diverse supporting documents, our experience with and knowledge of processing content for medical device companies gives our clients the confidence that their company’s documentation will meet regulatory requirements and language compliance.
Our flexibility and scalability for accommodating the needs of different groups and roles within a medical device company allow us to support a comprehensive range of documentation and information types. More importantly, we offer custom solutions to specifically address each group’s requirements for translation services. This may involve solutions for technical publications groups, engineering, regulatory affairs, marketing, human resources, training and development, and other groups with translation needs.
We also help establish better content management practices and consolidate the consumption of translation services across business units, so medical device companies can focus on their core competencies while we enable their content globalization.
Highlights of our service delivery for medical device companies include:
- ISO 9001:2008, ISO 13485:2003, and EN 15038:2006 certified
- Enhanced QA model (leverages LISA QA model and SAE J2450)
- Integrated project and information management, including reporting, through LUZ’s AURORA platform
- Expertise in life science subject matters and global regulatory requirements
- Certified and qualified linguists
- Qualified and trained project managers
- Dedicated project and language teams to ensure consistent and responsive service delivery as well as translation quality
- Significant cost savings through corporate volume discounts
- Coordination and management of in-country reviews
- Technology solution consulting
- Faster time to market and reduced product liability through best-practice translation workflows
- Creation and maintenance of translation memories
- Access to translation memories and project items
Content and Document Types
To ensure that medical device companies receive the right services and solutions, our dedicated project teams provide the needed expertise and technical abilities to process a variety of document formats using standard and unique publishing applications (e.g., InDesign, FrameMaker, QuarkXPress, Word, etc.), including structured authoring (e.g., XMetal XML Editor, Arbortext Editor, etc.) and software localization tools (e.g., Catalyst, Passolo, etc.).
Typical user documentation projects may involve 20-30 languages and multiple documents of varying length (e.g., 1–500 pages per document). Moreover, content may be reused across different media types, requiring publishing into multiple file formats (e.g., PDF, CHM/HTML, XML, etc.).
Our experience working with different documentation includes, but is not limited to the following content types (in alphabetical order):
- Computer-based training (CBTs)
- Customer letters
- Data sheets
- Directions for use (DFUs)
- HR policies
- Instructions for use (IFUs)
- Operational procedures (e.g., SOPs)
- Package inserts
- Reference guides
- Release notes
- User notifications/disclaimers
- User/operator’s manuals
- User interface/online help files
- Web content