Clinical Evaluation Of Reusable, Measuring and Sterile Class I Medical Devices

Class I medical devices under the EU MDR are considered low-risk devices. These medical devices are usually non-invasive and for transient use, such as hospital beds or bandages, or invasive tools used only transiently in body orifices, such as dental impression materials. Class I medical devices can be active, such as examination lamps. However, the MDCG 2021–24 Guidance on the classification of medical devices specifies three subclasses of Class I devices based on device-specific features, that do require assessment by a Notified Body. Class I medical devices are subdivided: Class Ir (Reusable Surgical Instruments): are instruments designed for multiple use after proper cleaning and sterilization [...]

Clinical Evaluation Of Reusable, Measuring and Sterile Class I Medical DevicesShareThoughts2025-01-11T10:43:17+00:00

Components of a PMCF Plan

Key Components of a PMCF Plan According to the European Union Medical Devices Regulation (EU) 2017/745, every manufacturer of medical devices must carry out periodic post-market clinical follow-up (PMCF) evaluations and collect and submit well-structured post-market surveillance reports regularly. It is a proactive process that collects and evaluates clinical data on the safety and performance of a medical device in normal use. According to the MDR Annex XIV Part B, PMCF should run continuously throughout the entire lifetime of a device. A PMCF Plan is required by the European Union Medical Device Regulation (MDR 2017/745) for Class IIa, IIb, [...]

Components of a PMCF PlanShareThoughts2025-01-07T10:36:01+00:00

ISO 13485 Certification in Saudi Arabia

ISO 13485 Certification in Saudi Arabia At present, the healthcare industry in Saudi Arabia is quickly developing. While the global demand for reliable medical supplies grows significantly, it is critical to establish the medical devices’ safety and effectiveness. This is where ISO 13485 certification in Saudi Arabia can come into the picture and offer a standard model for the organizations that get engaged in designing, developing, manufacturing, installing, and even supplying medical instruments. Hence the need to ascertain the quality and safety of health care devices in the modern international market. As for those companies that would look to wander [...]

ISO 13485 Certification in Saudi ArabiaShareThoughts2024-12-22T08:02:55+00:00

Update Clinical Evaluation Report

Update Your Clinical Evaluation Report Clinical evaluation report is essential because it assures that, during the entire time a medical device is on the market, assessments of its performance and safety are supported by enough clinical data. For first-time CE-marking, a clinical evaluation report is required, and it needs to be actively updated. For the duration of the device's life cycle, the clinical evaluation and its documentation should be updated with clinical data from the post-market surveillance system (PMS) and post-market clinical follow-up (PMCF). The frequency of updates is determined by your device's risk categorization and the PMS's output. Why [...]

Update Clinical Evaluation ReportShareThoughts2024-12-22T07:59:44+00:00

Medical Devices Sterilization

Medical Devices Sterilization Medical Devices Sterilization is a process that effectively destroys all microorganisms from the surface of an article or in a fluid to prevent disease transmission associated with the use of that item. Sterility is a state of being free from viable organisms. Most surgical and medical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. Medical devices that have contact with sterile body tissues or fluids are considered critical items. These items should be sterile when used because any microbial contamination could result in disease transmission. [...]

Medical Devices SterilizationShareThoughts2024-12-22T07:59:50+00:00

FDA Pre Submission For 510k

What is FDA 510k Pre Submission A FDA Pre Submission is a formal written request from a submitter for feedback from FDA that is provided in the form of either formal written response or, if the submitter chooses, formal written feedback followed by a meeting. Such a Pre Submission meeting can be in-person or by teleconference as the submitter prefers. A FDA Pre Submission provides the opportunity for a submitter to obtain FDA feedback prior to an intended premarket submission (i.e., IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND), In FDA Pre Submission face-to-face or teleconference meeting with [...]

FDA Pre Submission For 510kShareThoughts2023-09-12T11:32:29+00:00

BIOCOMPATIBILITY

Biocompatibility of Medical Devices Biocompatibility testing is a critical part of the regulatory approval process for medical devices as even the best-designed products could produce unintended complications if the materials used, cause a biological reaction in the patient. An integral part of biological risk assessment, biocompatibility testing assesses the compatibility of medical devices with the biological system. It studies the interaction between the device and the various types of living tissues and cells that are exposed to the device when it comes into contact with patients. Almost all medical devices that come in contact with human tissue require biocompatibility [...]

BIOCOMPATIBILITYShareThoughts2023-01-20T10:53:59+00:00

Quality in 510(k) Review Program Pilot

Quality in 510(k) Review Program Pilot Quality in 510k review program pilot (RPP) gives an different method to submit a 510k to the FDA via the eSubmitter software. ( For specific device types) On April 26, 2021, the FDA announced the decision to conclude the Quality in 510(k) Review Program Pilot. Quality in 510(k) Review Files will no longer be accepted by the FDA after May 30, 2021. The applicable medical device codes for this programme were also published by FDA. The Quality in 510(k) Review Program pilot's goal is to assess the program's effectiveness and determine whether using [...]

Quality in 510(k) Review Program PilotShareThoughts2022-07-30T14:30:16+00:00

Medical Device Reporting (MDR)

Medical Device Reporting (MDR) Medical Device Reporting (MDR) is one of the Postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Mandatory reporters are manufacturers, device user facilities, and importers. Hence Mandatory reporters are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. Manufacturers: Manufacturers [...]

Medical Device Reporting (MDR)ShareThoughts2022-07-30T10:48:39+00:00

Software Verification and Validation

Software Verification and Validation Software validation is a requirement of the Quality System regulation. Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in the production of the device or in the implementation of the device manufacturer's quality system. Software is frequently purchased off-the-shelf for a particular intended use so, it should have documented requirements that fully define its intended use, to show that the software is validated for its intended use. Device manufacturers may use the same procedures and records for compliance with quality [...]

Software Verification and ValidationShareThoughts2022-07-30T09:41:40+00:00

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