With more than 30 years of experience in providing life sciences translations for medical device manufacturers, pharmaceutical and clinical research organizations, and healthcare providers, we take our job very seriously.
We deal with all kinds of documents within the field of Life Sciences, including medical software and instructions for use, documentation relevant to the conduct of clinical trials, regulatory submissions for marketing authorization or training, and marketing materials for the promotion of medical products and services.
The content accompanying medical devices may consist of software, instructions, packaging, labels, or other kinds of related materials. What is critical in any medical device translation is to faithfully and accurately reproduce the original meaning, providing clear instructions to the intended audience, whether this includes medical professionals, technical users, or patients. This, in turn, will guarantee that the equipment is used correctly, safely, and as intended by the manufacturer. Compliance with international standards and the regulatory framework is also of vital importance in order to take your products global.
In our long history of providing translations for the life sciences sector, we have successfully localized medical device-related content for many different uses:
User manuals for medical devices
Instruction and installation manuals for medical devices
Quick reference guides
Instructions for Use
Packaging and labeling
Regulatory and compliance documentation
Software user interface and mobile apps
Marketing materials, brochures, newsletters and press releases
The most common challenges that pharmaceutical and biotechnology companies face are patient safety, regulatory compliance, and time to market. Our expert linguists and project managers can help you prepare your products for global markets throughout all stages of the product lifecycle, from regulatory approval to marketing, always keeping within your timeframe and budget.
Summary of product characteristics (SPCs)
Patient information leaflets (PILs)
EMA QRD Templates
E-learning content for pharmaceutical companies
Regulatory approval dossiers
Certificates of conformance
Informed consent forms
Patient information sheets
Frequently asked clinical questions (FAQs)
Clinical trial translations are highly complex and consist of a vast amount of documentation and accompanying materials, all of which must be localized within a set timeframe and to high standards. The work involves more than translation since additional services are often needed, such as linguistic validation, back translation, SME review, and readability testing, to name a few. Punctuality and quality are, of course, essential to meet the deadlines for regulatory submissions, but so is adherence to regulatory guidelines and international standards. Data security and patient engagement are two other important factors in this equation. Having worked on numerous clinical trial translation projects for some of the biggest clinical research organizations (CROs), we draw on this experience to provide you with a solid and thoroughly tested workflow that will guarantee flawless results on time and within budget.
Clinical study protocols
Informed Consent Forms (ICFs)
Patient Diaries & Patient-Reported Outcomes (PROs)
Clinical Outcome Assessments (COAs)
Clinician-Reported Outcomes (ClinROs)
Observer-Reported Outcomes (ObsROs)
Patient recruitment materials
Adverse event reporting
Powered by an experienced team of language specialists, ORCO optimizes your translation capabilities and empowers you to develop in the international markets.
Our production team consists of specialist translators with significant experience in various medical sectors. Many of our senior editors have relevant industry experience and/or an academic background in the medical discipline. Our team is further supported by a network of in-country native-language physicians/field experts.
Our dedicated project management team specializes in life sciences projects and counts many years of experience in successfully localizing different types of products for market-leading companies.
ISO-certified processes: We apply strict procedures and customized workflows to ensure high-quality results. Our quality management system is certified to ISO 9001 and ISO 17100 standards.
Expert translators: All projects are assigned to the most qualified medical experts that match your field or medical sector while accommodating the full translation/revision/quality control cycle followed for all life sciences assignments. All our associates are selected after a rigorous multi-stage recruitment process and matched to subject areas/projects depending on their skills and relevant experience.
Use of the latest translation technologies: Linguistic excellence is further ensured by effectively using language technologies, translation memories, and terminology management systems.