Smiths Interconnect’s Post

Let's talk about why it's so important to be able to talk about your medical device! And as always — don't hesitate to reach out for guidance or support in understanding how to better define the purpose of your novel medical device. We’re always happy to help! #Qmed #MedicalDevice #RegulatoryAffairs #ClinicalAffairs #MarketAccess

#WellnessWednesday: Medicines and medical devices: Five top tips for summer ! 😎 Before heading to the beach, read the MHRA's five top summer tips for people taking medicines or using medical devices > https://ow.ly/ZQy450SMX5m #Medicine #MedicalDevices #Summer

Interesting : "... 2.2. Consultation on a medical device composed of substances or combinations of substances that are systemically absorbed to achieve their intended purpose Definition 4 in Annex I shall apply by analogy to this section. The following classification and amounts shall apply for consultation on medical devices composed of substances or combinations of substances that are systemically absorbed to achieve their intended purpose. 2.2.1. Initial request EUR 80 500 for consultation on the compliance of medical devices composed of substance(s) or combination of substances that are systemically absorbed to achieve their intended purpose with the relevant requirements of Annex I to Directive 2001/83/EC. ..."

Planning your first clinical investigation? Conducting clinical investigations is mandatory for high-risk or innovative medical devices. However, understanding the complex requirements can often be challenging for any newcomers in the field. Head to our blog for a 5-step checklist to keep your project on the right track from the beginning! https://lnkd.in/dEMZY4kn #clinicalstudies #clinicalinvestigation #medicaldevices

#Didyouknow The Therapeutic Goods Administration has updated their guidances for the regulatory framework for personalised medical devices. 📍Refinements to the Personalised Medical Device Framework: https://lnkd.in/eKwzmbCd 📍Understanding personalised medical devices rules (including 3D-printed devices): https://lnkd.in/e2HSTAbV 📍How to submit a custom-made medical device and patient-matched medical device notification - step-by-step guide: https://lnkd.in/eT3CHka5 #medtechnews #medtech #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #regulatoryaffairs #Australia

"Standard Operating Procedures are the backbone of medical device manufacturing, ensuring consistency, quality, and compliance in every step of the process. They are not just guidelines; they are vital to safeguarding patient safety and fostering innovation." #greenveinhealthcare #motivatonmonday #motivationquote #medical #medical_device #needle #medical_disposables #hypodermic_syringes #hypodermic_needles #syringes

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

"The FDA regulates some 200,000 medical devices ... Yet, manufacturers rely on emails — and even traditional mail — to convey pertinent recall information" The Medical Device Recall Improvement Act would require medical device manufacturers to use an electronic format for recall notifications and include UDI to enhance communication between manufacturers, hospitals, and healthcare professionals.   Ensuring patient safety should be the highest priority for hospitals, and acting promptly on recalls is crucial to this. At SxanPro, we leverage UDI-based mobile technology to extract more than 10 data points from the barcode on medical devices, providing clear visibility into inventory. Our commitment to patient safety and inventory visibility is further reinforced by the new proposed bill that mandates medical device manufacturers to include UDI in their recall notifications. Although our technology is already designed to alert hospitals about recalls on their shelves using lot numbers, reference numbers, and serial numbers, the inclusion of UDI in recall notifications would significantly improve healthcare efficiency and reduce patient risk. Link to Article: https://lnkd.in/gyhz_PSg Link to Bill: https://lnkd.in/gngiyhj9 #patientsafety #recalls #fda #medicaldevicemanufacturing

Our new video is live, delving into the intricacies of Clinical Evaluation Reports (CER) for Medical Devices. 🏥 Explore the six key components that ensure safety and efficacy in device development. Enhance your understanding of CERs and stay at the forefront of clinical research! Watch now: https://zurl.co/W39k #MedicalDevices #ClinicalResearch #CERExplained

Intended purpose can be difficult to write. My collague Ase Ek has created this W... guide as a helpful resource. Think about measurability 📏 in everything you want to write about your Medical Device product – the product's effect must be demonstrated through a clinical evaluation. As the manufacturer, you must clearly determine how you will specifically prove that the product actually works according to its intended purpose. GBA Key2Compliance®