7 critical mistakes to avoid when translating IFUs and medical product labelling
Regulatory Affairs professionals operate under constant pressure from regulations such as the MDR and IVDR, which have turned documentation into a critical component of the medical product itself. The risk of non-compliance during an audit — and the regulatory, commercial and legal consequences that may follow — is a daily reality.
Specialist Translation in Clinical Trials: A Strategic Asset for CROs
Delivering a global clinical trial successfully is a complex operational challenge. For a Contract Research Organisation (CRO), the focus is firmly on execution: coordinating multiple stakeholders, countries, investigative sites and vendors while maintaining control over timelines, quality and compliance. Unlike sponsors, CROs are not measured by the commercial return of the asset, but
How to Design a Translation Workflow Compliant with MDR and ISO 13485 in 5 Steps
Regulatory and Quality leaders in the medical device industry face a significant challenge: meeting the demanding linguistic requirements of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) ahead of their respective 2028 and 2027 deadlines. This means translating documentation into as
Using AI for Translation: Stay MDR-Compliant
Are you using Machine Translation or AI to translate medical device documentation? Wondering whether that could lead to non-compliance with Regulation (EU) 2017/745 (MDR)? Here’s what you need to know.
The importance of ISO 17100 when choosing a translation partner
Choosing a translation partner can be a challenging undertaking. You want a partner with an established quality assurance process, expertise in the languages you need, strong data security protocols, a responsive project management team, and last but not least a company that can meet your
New deadline for the certification of medical devices under the Medical Devices Regulation (MDR)
On 7 March 2023, the Council adopted a regulation that extends the deadline for the certification of medical devices under the Medical Devices Regulation (MDR). The measure aims to allow the MedTech industry to continue to bring essential equipment to the market and ensure that
Certified Translation of Instructions for Use for Medical Devices
The primary objective of the translation is to provide users with clear and understandable guidelines for properly using medical devices. The most important aspect to keep in mind involves legal issues. Countries in the European Union dictate that the proper translation of instructions of use
New European Union Medical Device Regulation
What is MDR? The MDR is the new regulation for medical devices and sanitary products. Its main objective is to establish new requirements for the production and supply of medical devices in European territories while meeting high quality and safety standards. It appeared in response
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7 critical mistakes to avoid when translating IFUs and medical product labelling
Regulatory Affairs professionals operate under constant pressure from regulations such as the MDR and IVDR, which have turned documentation into a critical component of the medical product itself. The
