Regulatory criteria are tightening as the field of medical devices continues to develop. Technological developments have produced smaller, more intricate devices that frequently make use of cutting-edge plastics. Processes for validation and verification (V&V) have become extremely important in this situation. They not only make sure that laws are followed, but they also help to […]
The medical devices sector in Europe is experiencing rapid growth and transformation, driven by advancements in technology, developing regulations, and an aging population. In this post, we will discuss the latest trends, developments, and innovations in the European medical devices sector and their impact on the industry’s future. Challenges and opportunities in the Medical Devices […]
Gap analysis is a crucial step for any company seeking EU EUDAMED compliance, as it serves to identify the differences between the company’s current operations and the new regulation. With realizing EUDAMED, manufacturers of medical devices will be required to comply with new regulations and requirements that will have an impact on their operations and […]
CEP/CER, PSUR, and PMCF are essential components of the regulatory compliance requirements for the medical device industry. These regulatory documents are essential for ensuring the safety, efficacy, and quality of medical devices throughout their lifecycle. According to the new EU Medical Device Regulation, the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) are mandatory […]
The Swissmedic position paper on DCTs second version was published on 15th December 2022. The Swiss Agency prepared it for Therapeutic Products (Swissmedic). In this blog, we will discuss some of the most critical aspects of this document. Introduction What is a decentralized clinical trial? A decentralized clinical trial (DCT) is a research study in […]
The EU MDR is a new addition to an already existing set of medical device regulations. Medical device manufacturers looking forward to implementing MDR must understand the changes that MDR brings with it. Moreover, they must also understand the critical differences between EU MDR and the US FDA, another renowned regulatory framework. Differences between FDA […]
ISO 11608-1: An Introduction ISO 11608-1: is a standard that puts forward the requirements and testing methods concerning single–patient use of NIS (Needle-Based Injection System) for delivering a bolus of a medicinal product. The bolus can be delivered via needles or soft cannulas through intradermal, subcutaneous, or intramuscular routes. Additionally, these NISs can incorporate pre-filled […]
The UKCA (United Kingdom Conformity Assessed) marking is a product marking dedicated to products placed on the Britain markets (i.e., in England, Scotland, and Wales). The UKCA marking covers the following products: Aerosols Ecodesign Equipment for outdoor use Equipment for potentially explosive atmospheres (UKEX) Electromagnetic compatibility Gas appliances Lifts Low voltage electrical equipment Machinery Measuring […]
What is Control Strategy? A control strategy is comprehended as a planned set of controls derived from the understanding of process and product while assuring the product’s performance, process, and quality. The control strategy begins with understanding the product and process. In general, a control strategy comprises the following components:• Composition materials• Components• Constituent parts• […]
With its implementation, EU MDR has put forth a lot of new requirements for medical device manufacturers. One of these requirements concerns the manufacturers trying to get a CE mark for their devices. These requirements are set forward by GSPR, or General Safety Performance Requirements. What is GSPR? GSPR is a set of requirements in […]
Since there are 24 official languages in Europe, there is a need to translate information given on the labels into different languages. By using symbols as an alternative to written languages, these requirements can be met easily. In its Annex I, chapter III, 23.1.h., MDR has permitted the manufacturers to use the symbols in the […]
IoT or the Internet of Medical Things can be defined as a suite of medical devices and applications connected to the internet to allow real-time, rapid, and dynamic analysis. Trends on Internet of Medical Things Research from Deloitte UK’s center indicates that the IoMT market is projected to grow by $160 billion by 2022. This […]