Reducing risks and increasing ROI in life sciences translations

Applying a centralized translation process is a proven strategy to save on translation costs and turnaround time, reduce regulatory risks, and more importantly, improve content quality, and consistency across languages.

EU MDR Summary of Safety and Clinical Performance (SSCP) requirement: smart practices for multilingual compliance

We’re all aware of the impact EU Medical Device Regulation (MDR) has on product labeling, as many Medical Device companies have prepared their multilingual product documentation and labeling for compliance.

All you need to know about life science translations

Life science translation comprises medical documentation related to pharmaceutical products, medical devices and other health technologies that, at a minimum, can improve the quality of life for many people worldwide, and that ultimately can save human lives.

Handling MedTech regulatory requirements during industry growth

The MedTech market is expected to be worth USD 613 billion by 2025. As the value of the market grows, so does the volume and complexity of the associated regulated information that needs to be managed.  

An efficient alternative to drug labeling management

High-risk and labor-intensive processes are usually the low-hanging fruit for process and technical innovation. Creating and managing updates to global life sciences product labeling falls well within this category, providing plenty of scope for improvement.

New clinical trial regulation: finding the support you need

With the new EU Clinical Trial Regulation (No. 536/2014) going into effect starting January 2022, Clinical Operations teams within Sponsor and CRO companies should make sure that language service providers are ready to handle the impact of the new regulation. It establishes a Clinical Trials[...]

Beyond labeling: how MDR post-market surveillance impacts content

As the MDR deadline approaches, many Medical Device companies have updated their multilingual product documentation and labeling to be ready. However, compliance isn't done by simply updating product content before the deadline. The new regulation’s focus on post-market surveillance (PMS), product[...]

5 best practices to apply to your MDR/IVDR medical translations

With the MDR deadline approaching in May 2021, most medical device companies are well on their way to getting ready. Here at Acolad, we've been busy with over 250 of our medical device clients, providing medical translations in all EU languages for the MDR requirements.

Is your medical device documentation ready for EU MDR?

According to data from the European Union, there are over 500,000 different medical devices on the EU market. This could include anything from contact lenses to a hip replacement, or even bandages.

MDR/IVDR: structured content authoring might be the answer

Medical device companies creating product labeling and quality documentation with MDR/IVDR compliance in mind may find that their traditional approaches to these types of content may no longer work. The old document-based approach of creating IFUs, operating manuals, quality reports and technical[...]