Meddev Solutions

📣 Template alert! 📣 Introducing our clinical evaluation checklist template. It’s the perfect helping hand to ensure you’ve considered the key aspects when creating your clinical evidence. This checklist is designed to: ✔️ Help to guide your approach to clinical evaluation  ✔️ Help you critically challenge your clinical evaluation  ✔️ Help you to identify gaps in your clinical evaluation, giving you the chance to focus your attention in the right places All you need to do is download the checklist and work through the 7 sections to identify any potential gaps. And the best part? It’s written from the perspective of a Notified Body reviewer, helping you understand what the notified bodies are expecting to see. What are you waiting for? ⏰ Download now at the following link: https://lnkd.in/eK3xyPEr  Don’t forget to tag a friend or colleague who might find it useful! #ClinicalEvaluation #ClinicalEvaluationTemplate #Medtech #ClinicalEvaluationChecklist 

One of the key things to remember about clinical evaluation?    You’re never really finished with it 🤷🏽♀️ As you can see in the graphic below, clinical evaluation is an ongoing process.     Under MDR, the clinical requirements are relatively new. This means that people need to upskill now more than ever.     Maybe...  You want to learn best practice when it comes to writing and/or reviewing CER  You review CER documents in your organisation, and want to gain a better understanding of the MDR requirements    You have no previous knowledge of clinical evaluation and need an overview  You need a better understanding of the clinical evaluation process    If any of the above applies to you, it’s time to sign up to our Clinical Evaluation for Medical Devices training. Join us for 16 hours of virtual learning, complete with group activities and course materials that are all yours to keep.  Get exclusive access and join the waitlist now by emailing info@meddevsolutions.co.uk or calling +353 091 394 804.  #ClinicalEvalution #MedTech #LearnOnline #EUMDR #Training #LearnOnline #OnlineTraining #MedicalDevices 

Do you know the difference between clinical evidence and clinical data? 🤔      Perhaps you’re unsure who the key actors are in a clinical investigation. Or maybe you don’t quite know what goes into a clinical evaluation report. That's why we’ve compiled all the key definitions in one useful document 🙌      Download your FREE copy now: https://lnkd.in/efNpa5Ks       Need a little more support? Join the waitlist for our Clinical Evaluation for Medical Devices training. In this course, you’ll get up to speed with the clinical evaluation requirements under the EU MDR.      Be the first to know when the new dates are live! ▶️ Email info@meddevsolutions.co.uk or call +353 091 394 804 to learn more.    #ClinicalEvaluation #CER #MedTech #CERreport #EUMDR #MedicalDevices #ClinicalData #ClinicalEvaluationReport 

Thinking of upskilling? If so, it’s well worth getting a few colleagues involved! 💸 At Meddev Solutions, we offer discounts on group bookings, making training easier on your pocket. Here’s how it works:  📝 3 – 5 attendees get 15% OFF  📝 6 or more attendees get 20% OFF Got more than 8 attendees? Consider arranging in-house training. We work with you to customise the course, making sure it fits your exact needs! 💰 Funding Available 💰 Did you know that you can avail of funding through our partnerships with Skillnet Ireland? Drop us a message to find out how – it couldn’t be simpler. To get your discount, all you need to do is contact the team at info@meddevsolutions.co.uk or call +353 (0) 91 394 804. You can browse our upcoming training courses here: https://lnkd.in/dPFrkCB  #VirtualTraining #Medtech #MedicalDevice #BespokeTraining #Quality #Regulatory 

Struggling with Software as a Medical Device? Not for much longer! Our industry-leading experts have created a 22-hour course to help you understand the requirements of IEC 62304 – as well as the importance for medical device manufacturers.  By the end of the course, you will: ✅ Understand the purpose and structure of IEC 62304  ✅ Understand the key terms and definitions used through IEC 62304 (incl. SaMD, Software as a component or accessory, embedded software)  ✅ Be able to describe and understand all elements of IEC 62304 and the deliverables required based on Software Risk Classification  ✅ Understand the interconnection between Software Development, Design Control and Risk Management and Human Factors/Usability Engineering  ✅ Easily explain with working examples the key deliverables required from IEC 62304  ✅ Understand when IEC 60601 is required Identify Label Requirements for Software including UDI “The amount of materials and resources was great for reinforcing learning and addressing questions. Coupled with the trainer’s exceptional expertise, it truly made for a valuable experience.”   - Kiara G., March 2024 attendee Join us for our in-depth expert-led training on 4 – 7 November. BOOK NOW by visiting https://lnkd.in/eK3M6Yze, emailing at info@meddevsolutions.co.uk or calling +353 91 394 804. Remember that discounts are available on group bookings!  #Software #MedTech #LearnOnline #SaMD #Training #IEC62304 #SoftwareAsAMedicalDevice #MedicalDevices 

Have you ever thought about enrolling your team in training, but struggle to find one that perfectly fits your unique needs? This problem is more common than you think! After all, every business is unique, experiencing different challenges.  The solution? Bespoke training. At Meddev Solutions, we can customise courses to meet your own specific requirements. We work with you to identify your exact challenges, and develop solutions tailored to them. By crafting a training program that is unique to your company's culture and workforce, employees can gain the skills and knowledge necessary to overcome any future challenges. Click here to learn all about our Bespoke Training Framework: https://lnkd.in/e_KAsnMk  To learn more, email the team directly at info@meddevsolutions.co.uk, call us at +353 (0) 91 394 804, or visit our website at https://lnkd.in/ggNTRCh.  #Training #MedicalDevices #Medtech #BespokeTraining #TrainingFramework #VirtualTraining 

Is your team ready for the challenges to come? 🤔    As the rate of regulatory and quality updates moves at lightning speed, upskilling is essential in our industry. So why not join one of our expert-led training courses? From Clinical Evaluation to IVDR, we’ve got lots of topics to choose from. And guess what? You might even be eligible for funding. We’ve partnered with Irish Medtech Skillnet and Connected Health Skillnet to make sure your team can upskill without breaking the bank. Find out how to get a discount by emailing the team at info@meddevsolutions.co.uk or calling +353 (0) 91 394 804. You can also browse our upcoming training courses here: https://lnkd.in/dPFrkCB  #VirtualTraining #Medtech #MedicalDevice #BespokeTraining #BestValueTraining #Quality #Regulatory #IBEC #ClinicalEvaluation #IVDR 

Everyone is talking about PFAS these days – but what does it mean for you?    If you’re feeling confused, you’re not alone. With restrictions being proposed, it’s difficult to understand what they mean for your organisation.    If you want to get in control of PFAS, we’ve got the answer...     Our brand-new Introduction to PFAS course is now LIVE! Self-paced to fit to your schedule, learn the basics of PFAS in just one hour.    This training is perfect for...  ✅ Those working in the medical device sector   ✅ Those working in the regulatory space   ✅ People from all functions, e.g. Quality, Research & Development, Supply Chain and more   ✅ Those curious about what a restriction will mean for their organisation   ✅ Those interested in a primarily EU perspective    Sound like you? Book your place today: https://lnkd.in/e8xZbaG9     #PFAS #ForeverChemicals #MedicalDevices #MedtechIndustry #PFASConsulting #PFASChemicals #PFASban #PFASrestrictions 

Struggling with Software as a Medical Device? Not for much longer! Our team of experts have created a 22-hour course to help you understand the requirements of IEC 62304 – as well as its importance for medical device manufacturers.  By the end of the course, you will:  ✅ Understand the purpose and structure of IEC 62304   ✅ Understand the key terms and definitions used through IEC 62304 (incl. SaMD, Software as a component or accessory, embedded software)   ✅ Be able to describe and understand all elements of IEC 62304 and the deliverables required based on Software Risk Classification   ✅ Understand the interconnection between Software Development, Design Control and Risk Management and Human Factors/Usability Engineering   ✅ Be able to easily explain the key concepts of IEC 62304   ✅ Understand when IEC 60601 is required   ✅ Identify label requirements for software including UDI Join trainer Niamh St John Lynch on 4 – 7 November. Our last session sold out, so don’t miss out! BOOK NOW by visiting https://lnkd.in/eK3M6Yze, emailing at info@meddevsolutions.co.uk or calling +353 91 394 804. Don’t forget to claim your discount on group bookings!  #Software #MedTech #LearnOnline #SaMD #Training #IEC62304 #SoftwareAsAMedicalDevice #MedicalDevices 

The countdown is on! ⏳ Just one week to go until our best-selling Risk Management for Medical Devices training course begins. Discover how to identify, analyse, and control risks by going step-by-step through the key requirements, and how they integrate with MDR and IVDR. Once you’ve completed this in-depth training, you’ll be able to implement the requirements of ISO 14971 with total confidence! Join us for our expert-led Risk Management training on 16-18 September 2024. Our Senior Regulatory Expert, Dr Steve Curran, will share top tips and key insights to get you feeling confident with risk management. Grab some colleagues and PAY LESS 💰 Places are filling up, so book your seat FAST online at https://lnkd.in/eSuht84c  To get discounts and find out about all our training, email the team at info@meddevsolutions.co.uk or call +353 (0) 91 394 804. #Risk #RiskManagement #MedicalDevices #Training #MedTech #Upskilling #LifeSciences