NSF - Life Sciences’ Post

Click here to View all of our Training courses "https://bit.ly/3RuzmzO" NSF provides regulatory and quality medical device training courses and professional qualifications. Based on timely, real-world experience rooted in industry best practices and regulator insights. #medicaldevices #training #FDA #nsflearn

Online Training – Introduction to UKCA: Detailed overview of the UK MDR 2002, current regulatory landscape and upcoming changes   Several dates available in 2024 for: ✅ Focus General Medical Devices (1,5 Days Training) ✅ Focus IVDs (1 Day Training) ✅ Focus Medical Devices & IVDs (2 Days Training)   Unsettled with the transition of UK regulations? AKRA TEAM’s experience will support navigating you through the transition and understanding the regulatory requirements.  The online trainings are presented by our experts in the field of UK regulations: Senior Consultant @Hilola Hakimova. The trainings cover the various parts of the UK MDR 2002, providing you with the knowledge required to support regulatory compliance and ensure that you are up to date with the latest and upcoming regulatory changes.   Learn more and register now: https://lnkd.in/gjhR8WGX #RegulationInsights #training #online #UK #UKCA #regulatoryaffairs #medicaldevices #MDR #IVD

Online Training – Introduction to UKCA: Detailed overview of the UK MDR 2002, current regulatory landscape and upcoming changes   Several dates available in 2024 for: ✅ Focus General Medical Devices (1,5 Days Training) ✅ Focus IVDs (1 Day Training) ✅ Focus Medical Devices & IVDs (2 Days Training)   Unsettled with the transition of UK regulations? AKRA TEAM’s experience will support navigating you through the transition and understanding the regulatory requirements.  The online trainings are presented by our experts in the field of UK regulations: Senior Consultant @Jillan Hussein and Consultant @Hilola Hakimova. The trainings cover the various parts of the UK MDR 2002, providing you with the knowledge required to support regulatory compliance and ensure that you are up to date with the latest and upcoming regulatory changes.   Learn more and register now: https://lnkd.in/gjhR8WGX   #RegulationInsights #training #online #UK #UKCA #regulatoryaffairs #medicaldevices #MDR #IVD

𝗔𝗿𝗲 𝘆𝗼𝘂 𝗶𝗻𝘁𝗲𝗿𝗲𝘀𝘁𝗲𝗱 𝗶𝗻 𝗮 𝗜𝗦𝗢𝟮𝟬𝟵𝟭𝟲 𝘁𝗿𝗮𝗶𝗻𝗶𝗻𝗴? ISO20916 is also known as the Good Study Practice for IVD medical device clinical performance studies 🩺. Learning objectives 👇🏻 • Comprehend and apply the requirements of the ISO 20916 as a GSP guidance specifically for IVD medical device clinical performance studies from start to finish. • Understand how risk management is applied to all aspects of IVD medical device clinical performance studies. • Comprehend the different types of clinical performance study designs and how ISO 20916’s requirements apply. ❗Are you interested in this training? Add yourself to the waitinglist, as this training is about to be launched in October in a live online classroom training. #riannetooten #clinicalresearch #training #iso20916 #IVD #clinicalperformancestudy

Join Aaron Hage and Kathy Herzog for a 510(k) seminar in Rotterdam! Survivor: The FDA 510(k) Tuesday, 27 Feb - Wednesday, 28 Feb 2024 Hilton Rotterdam In the popular television series “Survivor,” individuals are placed on an island isolated from reality with odds stacked against them, fighting for their survival while the rulers of the island constantly change the rules, making it difficult to survive. Without knowing how to navigate the 510(k) program, and what alliances are critical for survival, a medical device company is likely to be an early exit from the FDA island. Most medical devices come to the American market through the 510(k) program. Although the regulations haven’t changed, the FDA has reshaped and expanded its expectations, leading to ever-increasing complexity in submitting 510(k) applications. Gaining an understanding of the program and its evolving expectations is like being equipped with the clothes, shelter, tools, and food essential to becoming the survivor. Join us in Rotterdam February 27-28, 2024 for a two-day workshop where regulatory experts will review the program’s requirements and expectations (including future proposed changes), provide strategies to help ensure success with program submissions, and arm you with the tools to be a “survivor.” Learning Objectives -Understand how to select an appropriate predicate device -Prepare a 510(k) submission that appropriately advocates for its clearance -Understand how to use available tools to get a submission-review process back on track -Know how to properly maintain a cleared 510(k) REGISTER: https://lnkd.in/eJRA6UDk

The objective of this course is to provide leaners with knowledge and understanding of the additional requirements within the Medical Device Regulation (MDR) as well as of the current directives (MDD 93/42/EE) and ISO 13485:2016, including the terminology used and the certification requirements.

🤔 Myth: "FDA approval means a device is completely safe and effective." 💡 Reality: FDA approval or clearance indicates that a device meets specific safety and efficacy #standards but doesn't guarantee absolute safety. All medical devices have #risks, and ongoing monitoring is essential. ☑ FDA approval or clearance is a critical step in the #regulatory process for medical devices. It means that a device has met specific criteria established by the FDA to ensure it is reasonably #safe and effective for its intended use. ☑ Before receiving approval, a device must undergo rigorous #testing and clinical #trials to demonstrate its safety and effectiveness and show how the device performs, its potential risks, and benefits. ☑ Although FDA approval signifies that the device's benefits outweigh its known risks, it doesn't imply that it is entirely risk-free. Medical devices can have side effects, complications, or unforeseen issues that may only become apparent after widespread use. ☑ The FDA continues to monitor the safety and performance of medical devices once they are on the market. This includes collecting reports of adverse events, conducting #inspections, and taking action if safety concerns arise. ☑ Patients and #healthcare providers must also play a role in ensuring the safe use of medical devices. They should be aware of potential risks, follow proper usage instructions, report any adverse events to the FDA, and weigh the potential benefits and risks when considering a medical device. ☑ In addition, the FDA continually updates its #regulations and #guidance to adapt to new information and evolving #technology. This means a device's safety profile can change over time as more data becomes available. ☑ It's also worth noting that regulatory processes and standards for medical devices can vary from country to country. What may be considered safe and effective in one country might have a different status in another. #QLeaRadvisors #QLeaRcares #WisdomWednesday #TruthvsMyth #MLV #MedicalDevices #FDAapproval #FDA #ClinicalTrials #QLaRity #compliance

📝𝗛𝗮𝘃𝗲 𝘆𝗼𝘂 𝗮𝗹𝗿𝗲𝗮𝗱𝘆 𝘀𝗶𝗴𝗻𝗲𝗱 𝘂𝗽 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗠𝗗𝗥 & 𝗧𝗵𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗟𝗮𝗻𝗱𝘀𝗰𝗮𝗽𝗲 𝘁𝗿𝗮𝗶𝗻𝗶𝗻𝗴 𝗼𝗻 𝗦𝗲𝗽𝘁𝗲𝗺𝗯𝗲𝗿 𝟱𝘁𝗵, 𝟮𝟬𝟮𝟯? After this training you will be able to: ✔ Indicate when something is a medical device or not ✔ Name the individual ingredients needed to place a medical device on the market ✔ Identify the applicable laws and regulations for medical devices ✔ Mapping the changes that the new regulation for medical devices entails ✔ Understand the differences between clinical evaluation and clinical investigation ✔ Comprehend the different types of regulatory pathways for obtaining regulatory approval of clinical investigations in Europe and The Netherlands ✔ Understand which documents are needed for the application from start to finish ✔ Identify the requirements during and after study conduct Take a look at https://lnkd.in/emiZ3M4P #EUMDR #medicaldevices #clinicalinvestigation #training #clinicalevaluation #riannetooten

The Medical Device Regulation (MDR) implemented by the European Union (EU) places significant emphasis on the role of the Person Responsible for Regulatory Compliance (PRRC). In addition to their responsibilities, the MDR outlines specific requirements for the education and training of PRRCs. This article will delve into the education and training obligations as defined by the MDR and shed light on auditors’ expectations, emphasizing the need for PRRCs to undergo specific training tailored to their role and maintain training records, including course certificates. Read the article and subscribe to the newsletter to get quarterly updates on the courses, latest insights and gain access to FREE templates! https://bit.ly/472zQmS

Afortiori Development Ltd is a full service CRO that can help you navigate any part of your clinical development journey should you need to carry out a clinical investigation. Also worth remembering that market needs should also drive your need for clinical evidence... #clinicaltrials #clinicalevidence #clinicalstrategy #clinicaldevelopmentplanning