Technical writing is a profession that only seems easy and straightforward. It requires finer skills and involves the usage of various tools to create the right content and get the information that is apt and easy to understand. The challenge for technical writing begins with an in-depth understanding of the product or service, staying abreast of its functionalities, and knowing and understanding the target audience.
- October 17, 2022 Medical Devices, Regulatory Affairs
- October 14, 2022 Medical Devices, Regulatory Affairs
Technical writing or technical documentation has evolved into a subject of growing significance in the world of written communication. Consider it as a natural offshoot of the knowledge-based economy, given its specialized nature, especially in the developed world.
- October 14, 2022 Pharmaceuticals, Regulatory Artwork Services
With digitalization taking up the world, some might say that paper leaflets are an outdated approach. Paper leaflet copies can become outdated whenever new safety or effectiveness information is released, making it challenging for manufacturers to update their leaflets.
- October 14, 2022 Pharmaceuticals, Regulatory Affairs
The World Health Organisation (WHO) declared the Global outbreak of Monkeypox as a Public Health Emergency of International Concern (PHEIC) on July 23, 2022. A week later, on July 29, 2022, Brazil recorded its first fatality (the first death caused by Monkeypox outside of Africa), according to Brazil’s Health Ministry.
- October 13, 2022 Regulatory Affairs, Publishing & Submissions, Regulatory Software & Services
eCTD has turned into a standard norm for industry-wide submissions in a majority of regions across the globe. It provided a single standard for the electronic transmission of submissions data and enabled the industry to communicate and exchange information with Health Authorities harmoniously.
- October 13, 2022 Medical Devices, Regulatory Affairs
The Class I medical device manufacturers are now focusing on transitioning from European Medical Device Directives (MDD) to Medical Devices Regulation (EU MDR) 2017/745. For the CE certificates issued under MDD before the implementation of MDR to remain valid until May 2024, this is applicable only under certain conditions. The devices that are under Class I are required to be compliant with MDR.
- October 12, 2022 Medical Devices, Regulatory Affairs
The European Union Medical Devices Regulation (EU MDR) 2017/745 defines the scope of the sterile medical devices as devices that must be microorganism-free (bacteria, viruses, etc.). Class I devices with sterile function can also obtain a self-certification, but it differs in terms of requirements compared to other sub-categories of Class I devices.
- October 11, 2022 Medical Devices, Regulatory Affairs
Innovations in medical devices have increased manifold in recent years. This acceleration can be especially attributed to the vast development in cloud computing and the Internet of Things (IoT). Similarly, Software as a Medical Device (SaMD) has seen an increase in demand and remains a major contributor to the overall growth of the device industry.
- October 7, 2022 Regulatory Affairs, Regulatory Software & Services
In September 2022, the USFDA released a revised technical conformance guide for electronic Common Technical Document (eCTD) v4.0. The guide provides specifications, recommendations, and general considerations while submitting eCTD-based electronic submissions to the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER).
- October 6, 2022 Pharmaceuticals, Regulatory Labeling
A Summary of Product Characteristics (SmPC) is an easy-to-access and product-specific resource enclosed with all the essential information about a product. The document includes the forms, clinical parameters, and pharmacological properties written and updated by organizations depending on their research and knowledge of a specific medicinal product.