Unlike medicinal products, medical devices require technical expertise in addition to medical knowledge, which poses a unique challenge during translation.
At DWL we have the knowledge and experience to handle technical documentation and produce translations that are clear, accurate and fit for purpose.
Medical devices are a key component of quality healthcare provision, and can be developed both in conjunction with, and independently from, medicinal products.
DWL is involved in important translation activities relating to medical devices, including but not limited to:
- Instructions for use (IFUs)
- Field safety notices
- Operating/Instruction manuals
- Surgical brochures
- Patient leaflets
- Package inserts and labelling
- Data sheets
- Technical specifications
- Marketing materials
The advantages to using DWL for medical device translations include:
- Our experience in translating documents using precise language tailored to the patient, caregiver or physician.
- Our technology which ensures that Adobe InDesign marketing materials are easily handled and returned in the same format.
- The support we offer in planning medical device registration in cooperation with European regulatory consultants.
- Our in-house medical expertise and the professional knowledge and experience of our freelance linguists.
DWL can help your product reach the market with our tailored processes and strict Quality Management System. This includes ensuring compliance with existing regulations, and particularly with the EU Regulation on Medical Devices 2017/745, and the EU Regulation on In Vitro Diagnostic Medical Devices 2017/746.