Whatever language patients and clinicians speak, it’s vital they understand how to use your medical devices correctly. That’s why Conversis ensures your instructions, labelling and product guides are accurately translated into the user’s language, so you can eliminate the risk of misunderstanding and misuse.
Both medical device and in-vitro device translations must comply with demanding industry standards 2017/745 and 2017/746 respectively. The regulation requires manufacturers to include the EU’s Summary of Safety and Clinical Performance (SSCP).
Under these regulations, medical device translations must take into account readability when addressing healthcare professionals and patients. Quality, formatting and consistency are also essential components and need to be underpinned by an ISO 9001 Quality Management System.
Conversis is a translation partner that understands regulations and the impact they have on translation requirements
Ensure all relevant audiences clearly understand your medical device content, from healthcare professionals to adult and child patients.
At Conversis we understand the regulations, your requirements and your workflows to ensure a compliant, efficient and quality translation process
