For medical environments to remain safe and effective, sterilization of equipment and devices is essential. This procedure gets rid of all microbiological life, such as spores, fungi, viruses, and bacteria. Doing so is crucial to stopping the spread of illness, particularly during operations where sterile bodily fluids or tissues are involved. Sterilization lowers the possibility […]
The medical device manufacturing industry is heavily regulated. Every country and jurisdiction have their own set of rules and regulations to govern the medical device industry, the manufacturing of the medical devices, their marketing, their clinical implications, etc. Although medical device regulations can be tailored and adapted according to the preferences of individual countries, some […]
Introductory Remarks Continuing our examination of the MDR/IVDR transition period, we delve into the transition period’s subtler points. In this section, we examine the conditions manufacturers must meet in order to benefit from the extended transition, as well as the evidence required to support this procedure. In addition, we explicate the nuances of transitioning surveillance […]
Introductory Remarks With the amendment of the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) by Regulation (EU) 2023/607, the world of medical devices is enduring a revolutionary transformation. This amendment should accomplish several important goals, including ensuring a robust level of public health protection, augmenting patient safety, and preventing disruptions in […]
Manufacturers in the dynamic global medical device sector today are subject to a wide range of compliance assessments from different regulatory agencies wherever they operate whether its hometown and export zones. The hurdles are many, ranging from CE mark certification through surveillance and recertification audits by notified organizations and regulatory evaluations by organizations including the […]
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 […]