O ur ISO 13485 consultants have hands-on expertise setting up quality management system for medical devices designers, manufactures, exporters and traders, service establishments and testing laboratories. By providing consultation, access to sample documentation, and online resources, we will walk you through the process. We can support you with your ISO 13485 Certification assessment and assist [...]
M edical Device Clinical Evaluation is a procedure to collect, assess, analyze a clinical data based on a clinical device to analyze whether there is sufficient clinical evidence to confirm compliance with essential safety and performance requirements when using according to manufacture instruction of use.it is applicable to all classes of medical device based [...]
B iological safety of the medical device is an important requirement for market approval. It is important for a medical device manufacturer to evaluate the potential risk of a medical device to a patient or user. This evaluation alone does not suffice, the medical device manufacturers need to address the potential risk of the [...]
SRN for Medical Devices: The Single Registration Number (SRN Number) identifies every economic operator in and outside of EUDAMED. The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain a single registration number (SRN). The SRN is issued once the relevant competent authority [...]
The basis of your device CERs is Literature Search. If you're in charge of compliance for a number of goods, you're well aware that EU MDR presents a significant challenge to your team and current timeframes. If you're a smaller manufacturer, you're probably just dealing with one or two people who are responsible for [...]
Medical Device Labelling: A label is the written, printed, or visual information that appears on the medical device itself, as well as the packaging of individual units or numerous medical devices. To avoid non-compliance, manufacturers must ensure that their product labels include all of the following elements: Name of the device The serial number [...]
The 510(k) summary is an abstract of the details related to the proposed device included in the 510(k) file and the supporting information. This document will include details about the device, manufacturer, predicate device chosen and substantial equivalence comparison with the predicate device selected. The details of the various nonclinical tests and clinical trials [...]
A information supplied by the manufacturer to inform the user of a product's intended purpose and appropriate use is referred to as "instructions for use." The following items must be present in the information provided with the directions for use: Information in line with Section 23.2 of the MDR points (a), (c), (e), (f), [...]
What exactly is a Single Registration Number (SRN)? The Single Registration Number (SRN) is a unique code that is used to identify an economic operator in the EU without ambiguity. The SRN number is generated by EUDAMED and issued by the competent authority who validated the Actor registration request in EUDAMED. Manufacturers must apply [...]
EUDAMED is the European Medical Device Databank. It's a safe, web-based portal that serves as a hub for information exchange between national authorities and the European Commission. The portal is not accessible to the public. EUDAMED came into force in May 2011 intending to improve market surveillance and transparency in the setup of medical [...]
