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Update Clinical Evaluation Report

ShareThoughts2023-09-13T07:04:39+00:00

Update Your Clinical Evaluation Report Clinical evaluation 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 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 Frequency of [...]

Update Clinical Evaluation ReportShareThoughts2023-09-13T07:04:39+00:00

Medical Devices Sterilization

ShareThoughts2023-04-07T04:41:01+00:00

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 SterilizationShareThoughts2023-04-07T04:41:01+00:00

FDA Pre Submission For 510k

ShareThoughts2023-09-12T11:32:29+00:00

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

ShareThoughts2023-01-20T10:53:59+00:00

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

ShareThoughts2022-07-30T14:30:16+00:00

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)

ShareThoughts2022-07-30T10:48:39+00:00

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

ShareThoughts2022-07-30T09:41:40+00:00

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

Medical Device Labelling in 510k

ShareThoughts2022-07-02T10:28:39+00:00

Medical Device Labelling in 510k Medical Device Labelling in 510k : Label is display of written, printed, or graphic matter upon the container of any article/medical device, it includes details like instructions for proper use, requirements for operating device safely, storage and maintenance and installation requirements, it also includes information that when particular medical device is put up for sale in the market. It must be clearly visible even if they contain is having any additional packaging. Medical labelling must follow instructions listed on FDA CFR 21 Part 801. No false information should be displayed on label. In addition [...]

Medical Device Labelling in 510kShareThoughts2022-07-02T10:28:39+00:00

FDA Medical Device Shelf Life

ShareThoughts2023-08-09T11:10:32+00:00

FDA Medical Device Shelf Life FDA Medical device shelf life is the length of time you can expect a product to look and act as expected and to stay safe for use. This length of time varies, depending on the type of product, how it is used, and how it is stored. Medical devices containing highly sophisticated electronics that are lasting longer than before, raising the bar for safety and liability. The concept of shelf life (expiration) date was created to help consumers realize when a product should be discarded. Expiration date states the termination of medical device shelf life. [...]

FDA Medical Device Shelf LifeShareThoughts2023-08-09T11:10:32+00:00

Medical Device Sterilization

ShareThoughts2022-06-10T18:22:51+00:00

Medical Device Sterilization 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. Such items include surgical instruments, biopsy forceps, and implanted medical devices. Sterilization is a process that effectively destroy all microorganisms from the surface of an article or in a fluid to prevent disease transmission associated with the use of that item. [...]

Medical Device SterilizationShareThoughts2022-06-10T18:22:51+00:00

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