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.

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[...]

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[...]

5 translation tips for CROs

International studies run by CROs are essential to the pharmaceutical industry, but the high level of regulation required by multiple governing bodies makes running a clinical trial a complex undertaking. 

All You Need To Know About Life Science Translations

Life science translation comprises medical documentation related to medicines and medico-technical equipment that at a minimum can improve the quality of life for many people worldwide, and that ultimately can save human lives.

Translating for the Pharmaceutical Sector: What Registers of Language Are Involved?

When it comes to pharmaceutical translations, some specific factors need to be considered, one of which is the target audience.