Ensuring MDR Compliance: Looming Challenges in the Eu for Medical Device Manufacturers
By the last day of 2027, over half of a million medical devices currently approved for sale in the European Union will need to have achieved recertification of compliance with the most recent and significant regulation in the EU concerning medical devices: the Medical Devices Regulation (MDR) (EU) 2017/745. Doing so will not simply be a matter of resubmitting previous applications with original clinical trial data. Medical devices already launched on the EU market will need to comply with the newly defined recertification rules as per MRD (EU) 2017/745. As part of the re-certification process and depending on their risk class1, the device manufacturers (i.e. medical devices classified in the Class III risk class) will need to either demonstrate safety and performance of their products using real world data collected as part of their routine medical use and/or demonstrate safety and performance using data generated in clinical investigations. In this white paper, we present a novel solution for medical devices seeking recertification that seamlessly supports their needs for clinical research, real world data generation, and multilingual communications in obtaining recertification of compliance.
Preparing for Regulatory Submission with Pharmaceutical Labeling Translations
Preparing for regulatory submission for a pharmaceutical product can often feel like an overwhelming task. The submission process for both clinical trials and market authorization requires not only meeting ever-changing regulatory requirements for documents and label formatting, but also increasingly is a crucial way to communicate to patients and providers, making considerations around patient centricity paramount. This white paper explores why working with a certified language service provider to integrate regulatory best practices with patient-centric language is essential to providing effective medical translations for pharmaceutical labeling.
Medical Communications and Medical Media in Patient Recruitment and Patient Engagement
Medical communications and medical media are driving forces behind some of the most significant advances in patient recruitment and patient engagement in the current clinical trial landscape. Since the COVID-19 pandemic, clinical trial models have shifted to become increasingly decentralized in structure, with an increased number of trials being conducted remotely and from trial participants’ homes as the much of the world remained restricted in travel.
Clinical Trial Translations:
New Requirements for Localization Under the European Union Clinical Trials Regulation (EU-CTR 536/2014)
The new EU-CTR has been crafted to harmonize the submission, assessment, and supervision of clinical trials with new objectives and guidelines. With these massive regulatory changes taking effect now in EU, this white paper highlights some of the specific changes that will dictate how clinical trials are conducted going forward and what applicants can expect from the updated approval process, particularly where support from language service providers (LSPs) will prove essential.
Tracking the Globalization of Clinical Trials:
Evolving Trends in Site Selection, Trial Reputation, and Localization
With an increased focus on developing cost-effective manufacturing processes, an emergence of innovative technologies, improvements in regulatory transparency, and a dramatic increase of resources allocated to innovation and research, the biopharmaceutical landscape has experienced a dramatic transformation.
Medical Device Market Overview and Regulatory Landscape in Latin America
Latin America (LATAM) promises to be one of the most profitable markets for clients in the medical device industry. As part of CSOFT’s series on the global life sciences market and regulatory landscape, this white paper will discuss the Latin American market’s medical device industry and regulatory landscape.
Machine Translation for the Life Science Industries: The Myth and the Truth
The rapid development of artificial intelligence (AI) and machine
learning has provided the translation industry with new capabilities,
such as machine translation (MT).
The EU MDR Labeling Journey:
Best Practices for Navigating the Latest Medical Device Labeling Requirements
The European Union’s regulatory landscape underwent a significant shift when the Medical Devices Regulation (EU) 2017/745 (EU MDR) officially went into effect on May 26, 20171.
A New Era of Patient-Centricity
Patient-centricity has become one of the new catch phrases of the pharmaceutical industry. Indeed, although the industry appears to have patient-centricity in its DNA, the voices of the patients can easily get lost in all the hundreds of details in the drug development process.
Medical Device Market Overview and Regulatory Landscape in Asia
Asia is on course to become the next hot spot for global medical device companies, as the region witnesses economic growth, increased health care spending, and robust regulatory reforms. In this white paper, part of CSOFT’s series on the global life science market and regulatory landscape, the Asian medical device market’s landscape and regulatory overview will be discussed.
China’s Ambitious Path Towards Universal Health Coverage (UHC)
In the last publication of CSOFT’s series on China’s healthcare reforms, the topic of how China’s radical regulatory makeover is shaking the entire pharmaceutical industry, both globally and domestically, was discussed.
Ensuring Quality in a Strategic Medical Writing Partnership
We are talking about two things here – quality, and medical writing – so first let’s examine both of these terms. Quality really means different things to different people – some consider it to be a degree of excellence, while others may see it as ‘being fit for purpose’. While perfection would be desired, it is always important to balance effort against output. Hence, rather than targeting perfection, it is important to focus on what matters: those critical data points that will make all the difference.
How the NMPA is Changing the Chinese Pharmaceutical Industry
Since 2015, the NMPA (CFDA) has initiated a series of reform documents, with the purpose of pushing the Chinese pharmaceutical and medical device industry to a more mature and globalized environment.
How to Get Ready for eCTD Submission
China is currently recognized as the world second largest pharmaceutical market. However, the regulatory policies have been very challenging for many large foreign pharmaceutical enterprises, as well as innovative local companies.
‘Qwality’ Not Included
The ability to rate translation quality in an effective and uniform manner has long been a requirement of the industry, but is also crucial to high-risk projects such as translation for patient safety medical device labelling.
The Ins and Outs of Translation Memory Maintenance
Translation memory is a vital part of your business’s assets. As your business experiences change and grow, your TM will expand as well. In an ideal situation, it should continuously learn your company’s multilingual content and improve itself to provide you with efficiency, accuracy, and low costs that are necessary for successful globalization. Whereas in reality, it often collects and stores unwanted data.