Therapeutic Goods Administration’s Post

Personalised medical devices are specifically designed and manufactured to meet the needs of an individual. We use three specific terms to describe personalised medical devices: • patient-matched • adaptable • custom-made Both patient-matched and custom-made medical devices are personalised before they are manufactured, unlike adaptable medical devices that are personalised after manufacturing. Find out more information about personalised medical devices: https://lnkd.in/g9UepQyC

IMDRF posted a new guideline: 'Personalized Medical Devices – Regulatory Pathways'. The guidance defines three categories of PMD's: custom-made medical devices, patient-matched medical devices, and adaptable medical devices. Interesting guideline with clear definitions and boundaries. https://lnkd.in/ds5u7hmr

The Medical Device Regulation: Why is there a need for clinical expert involvement in developing new medical devices? In this guest blog from Esther Daemen, we look at the need for the involvement of clinical experts in developing new medical devices, from concept to completion, and the importance of adhering to the new Medical Device Regulation (MDR). More: https://lnkd.in/eisRjFuT #gcpcentral #thereisabetterway #medicaldevices #clinicalresearch #experts

Exploring the 8 Stages of Medical Device Development 🩺 Creating a medical device is a journey worth understanding. Join us as we outline the 8 key phases involved in developing medical devices. Whether you're a #Healthcare pro or simply curious, this guide is for you: https://hubs.li/Q022jrp20

Don't miss the webinar ''Strategic Implementation of ISO 10993-17: Disposable Medical Devices'' with Raina Sota and Paolo Pescio, ERT We want to give an overview of the new Part 17 of ISO 10993, discussing the main and new key concepts described in it and focusing on its applicability in relation to specific types of devices, such as disposable medical devices. Some of these new concepts will be analyzed in order to determine when and how they can be applied to specific cases with the goal of defining increasingly tailored strategies for different medical devices. Click here to register 👉 https://lnkd.in/dP9izaTD

Refurbished Medical Equipment: Transforming Lives, One Device at a Time! Did you know that Refurbished medical equipment can make a profound impact on both the environment and communities in need? Here's why embracing medical equipment Refurbished is a game-changer: Read More https://shorturl.at/dpyJP #MedicalRefurbished #SustainableHealthcare #ImpactfulChange #ReadMore #Medinnova

Medical devices are reprocessed in several steps, in a specific order, a documentation is mandatory for some steps. The specific order of reprocessing is part of the so-called medical device cycle. Before you can start processing, it must be defined which products may be processed and how, by using a classification model for medical devices. If you want to learn more, register at https://ow.ly/8Bep50PUF2l for Module 11.0: Processing of Medical Devices in the Supply Chain I #MMMGroup #Protectinghumanhealth #RUMEDAcademy #Winglet #ReprocessingTechnicianRUMED

The Joint Commission releases a new guide on reprocessing medical devices. #spdceus #education #decontam #decontamination #steriletech #sterileprocessing #sterileservices #centralservice #centralservicetechnician #centralservicetechnicians #reprocessing #sterileprocessingtech #centralservicetechnicians  #reprocessing #spd #endoscopy #patientsafety

💉📕Changes to the legal requirements for products without an intended medical purpose – what does this mean for manufacturers and users? Products without an intended medical purpose include contact lenses without vision correction, products for fat reduction and dermal fillers, and laser devices to improve the complexion. They have all been subject to the Medical Devices Ordinance since 1 November 2023 and are now treated as medical devices. Thus the legal requirements have changed. What does this mean for the manufacturers of these products? And what will change for the users of such devices? 🎥🎞️Our two explanatory videos provide the answers.👇

Processing of reusable medical devices (RMD's) For the purpose of this guide a Reusable Medical Device (RMD) means: An item that is not intended by its manufacturer for single-use. A medical device designated or intended by the manufacturer as suitable for reprocessing.