When medical devices go global, medical device documentation must too. But for faster regulatory approval abroad and the best in-country results, manufacturers need to count on compliant, accurate medical device documentation translation that only experienced, highly-specialized translation companies like Responsive Translation can provide.
Maintaining appropriate documentary evidence following Good Documentation Practice throughout the medical device design, development and manufacturing process is key for quality management, risk management and regulatory approval. Good Documentation Practice originated in the pharmaceutical industry, but it is widely followed for a reason in the medical device industry too.
While three common components of medical device documentation are the design history file, device master record and device history record, different target markets for medical devices will have different documentation requirements. Many manufacturers consider the US and China to have more stringent requirements than Canada and the European Union. At the same time, it is important to present medical device documentation to the regulatory authorities for that target market in the appropriate national language.
As a strategic partner, Responsive Translation can help you meet different regulatory requirements and provide high-quality medical device documentation translation and review for any medical device market.
Responsive Translation has been providing high-stakes translation to medical device companies and other compliance-intensive industries for more than 30 years. Dedicated to quality and customer satisfaction, we offer translation, localization, validation and review in over 200 languages and dialects.
We take quality management and quality assurance seriously. We are ISO 9001 and ISO 13485 certified, and provide customized QA workflows to meet all of your regulatory requirements, as well as your budget and timeframe. Using advanced terminology and translation memory management together with our network of specialized translators and subject matter experts, we are able to work up to 60% faster than agency competitors without sacrificing quality. That’s one of the reasons why Responsive Translation received an NPS score of 100 for 2023, as audited by SRI. Let us show you how we can be a strategic partner for your medical device documentation translation.
To discuss your medical device documentation translation requirements, or to receive more information about Responsive Translation’s suite of medical device translation, localization, validation and review services, please contact us at +1-212-818-1102 or [email protected].