Medical Device Translations
Regulatory Implications
Medical devices are clinical products used by patients, humans, or used on them in a medical procedure, diagnosis, therapy, etc. Worldwide, the regulation of these products is getting more strict as they have medical and health implications. To be able to meet the needs of regulators, manufacturers need to provide seamless and prompt document localization and translation process. We provide a customized medical device translation protocol that is constantly updated for every locality and jurisdiction. This protocol is written by our medical expert teams and clinical experts, respecting local regulations, international best practices, and ISO certifications.
Our Quality Protocols
Since Medical device localization responsibility is being assigned to the manufacturer by the regulatory entities in many countries, manufacturers have to be careful choosing the best translation and cultural localization experts to avoid any regulatory delays. Our Approach towards medical device translation is based on combining local regulations, ISO 13845:2016 standards, and best quality assessment standards ( J2450 Translation Quality Metric). Furthermore, we provide cultural and local clinical consultation to localize the content to multiple localities, languages, and cultures. This enables us to provide a customized approach taking into account, translation, layout, setting, and more.
Do you want to learn more about our plan and protocols for your specific product?
We Support Your Medical Device Needs
Medical devices are divided into 3 categories:
Class I devices are low-risk devices.
Class II devices are intermediate-risk devices.
3-Class III devices are high-risk devices.
We provide our services to all category devices, however, the approach differs.
Among the Devices that we support:
Web applications.
Mobile Applications.
Surgical Equipment.
Elderly Aids and appliances.
Renal stent.
High-frequency ventilators.
Breast implants.
Technology
Our Vagus Software gives you the ability to manage the project yourself with our team of translators being at your disposal and under your full supervision, like an in-house team. You will have the ability to choose your team out of our pool of medical translators, clinicians, regulatory consultants, and reviewers, we will build the working program with you using our customized software that will be able to ensure all procedures are compatible with regulations (like MDR 2017/745, ISO13845:2016) and that all deadlines are met.
Interested in learning more about how Vagus Software can meet your needs?
Our Experience
Our field experience is vast, combining clinical trial knowledge, medical device regulation knowledge, and medical linguistic specificities. Furthermore, the professionals that we include in your projects are highly proficient with years of proven experience in the field. Many leading pharmaceutical and medical device companies trust us in migrating their content through the medical device localization processes, we can share with you specific case studies upon request.
Our Data Security Measures
All of our projects and operations are ISO 27001 and GDPR compliant. Our data security is handled by a special IT team that is in charge of applying the latest security practices. Furthermore, all of our workers are guided by our IT team to comply with all of our security and data protection procedures. Our systems are routinely audited by both authorities and private third-party editors to keep our systems protected and the protocols up to date. Furthermore, our technologies and software (like Vagus/Valitracks), have been built with a high-security focus, making sure all of our communications and operations are done with the most secured channels in the market.
Let's talk
If you like to discuss any specific project or explore more about our abilities, give us a call.
+1-302-415-3221 +30-694-066-3670 Contact us Frequently asked questions
