The Tao of Excellence

Are you an #importer of #medicaldevices in #Switzerland? 🇨🇭 Are you confronted with the obligations associated with this role? Then this importer training is for you! 👉 https://lnkd.in/e9gRyGZq 🔹 Online access and on demand 🔹 Swiss focus 🔹 MedDO requirements and corresponding MDR references 🔹 Modular design to allow a digestible approach 🔹 Experience based relevance of content 🔹 Certificate after successful completion Enhance your expertise as a Swiss medical device importer with our comprehensive online course. Tailored specifically for Swiss importers, this course demystifies the regulatory landscape and delves deeply into the MedDO requirements, alongside relevant MDR references. Our modular design ensures easy comprehension, allowing you to absorb the material at your own pace. This engaging, experience-based training spans 11 modules, accessible anytime, anywhere. Whether you’re starting fresh or looking to expand your knowledge, no prior experience is needed. Complete the course in just 6-8 hours and earn a certificate of completion, marking your newfound proficiency in the field. Get ready to elevate your role as a medical device importer in Switzerland with this essential training! For more information click here 👉 https://lnkd.in/e9gRyGZq Or contact us at ☞ meetus@taoexcellence.ch #importertraining #compliance #MedDO #IvDO #regulatoryaffairs #MDR #IVDR #swissimporter #swissmarket #qualitymanagement #readiness #innovation #success #medtech #medtechindustry #regulatorycompliance #health

For #medicaldevice manufacturers in the #EU. 🇪🇺 Team-NB’s press release highlights the progress made regarding the European Reference Laboratories #EURLs oversight of Class D devices under the In Vitro Diagnostic Regulation #IVDR, following the October 1, 2024, transition to operational status. Notified Bodies (NBs) have been working closely with EURLs to standardize the processes for batch release and performance verification of Class D devices, which includes the development of a consolidated Multi Services Agreement (MSA) template. This template has been endorsed by NBs to formalize the agreement and workflow between NBs and EURLs, supporting the implementation of the IVDR. The MSA is crucial for the efficient execution of performance verification and batch testing, as required by Regulation (EU) 2023/2713. Notified Bodies are now applying this MSA template to ensure a swift and compliant transition. The implementation of EURL testing is key for the regulatory infrastructure of the IVDR, aimed at ensuring the safety and compliance of in vitro diagnostic devices used in tissue compatibility and blood supply testing in Europe. We are here to support you in completing your technical documentation or identify gaps for a smooth review process with your notified body. This helps you save costs and time to market!Reach out to us ☞ meetus@taoexcellence.ch #regulatoryaffairs #regulatorycompliance #invitrodiagnostics #MDR #qualitymanagement #Notifiedbodies #NBs #EURegulation #medtech #technicaldocumentation #QMS #riskmanagement 

For #medicaldevice manufacturers in #Australia. 🇦🇺 The Therapeutic Goods Administration’s #TGA Australian Regulatory Guidelines for Medical Devices #ARGMD serve as a comprehensive index, providing guidance on the regulation of medical devices in Australia. These guidelines are updated to ensure manufacturers meet all requirements for market inclusion, ongoing compliance, and safety. The ARGMD index includes: 🔹 Medical Device Inclusion: Detailed requirements for manufacturers to include their medical devices in the Australian Register of Therapeutic Goods (ARTG), covering device classification, necessary evidence, and associated fees. 🔹 Essential Principles: Legislative requirements focusing on safety and performance of medical devices, including In Vitro Diagnostic (IVD) devices. The Essential Principles checklist assists manufacturers in proving compliance with these standards. 🔹 Conformity Assessment: A rigorous evaluation process where manufacturers demonstrate compliance with the Essential Principles. This includes required documentation and, for higher-risk devices, certified quality management systems and TGA-issued conformity certificates. 🔹 Global Medical Device Nomenclature (GMDN): Essential for obtaining ARTG inclusion, this nomenclature ensures consistent communication across regulators and manufacturers. 🔹 Post-Market Requirements: Ongoing obligations after a device is included in the ARTG, including mandatory reporting of adverse events, annual reviews, and managing product recalls. For manufacturers and stakeholders in the healthcare industry, understanding and adhering to the ARGMD guidelines is crucial for ensuring that devices meet regulatory standards throughout their lifecycle—from pre-market approval to post-market surveillance. The ever-changing landscape of medical device regulations in Australia can be complex. Don't hesitate to contact us if you have any questions or need assistance with your application. ☞ meetus@taoexcellence.ch #RegulatoryAffairs #Compliance #HealthcareRegulation #MedicalDeviceManufacturers #IVD #QualityManagement #PostMarketSurveillance #QMS #medtech #healthcare #riskmanagemen

For manufacturers of #medicaldevices in the #EU. 🇪🇺 The European Commission has launched a public consultation and call for evidence as part of the targeted evaluation of the EU’s legislation on medical devices and in vitro diagnostic medical devices #IVDs. This evaluation provides stakeholders with the opportunity to share their views on how the current rules are performing, including any shortcomings or areas for improvement. The assessment will examine the regulations' effectiveness, their costs and administrative burden—particularly for SMEs—and their impact on the availability of devices, such as ‘orphan devices,’ as well as on the development of innovative technologies. The aim is to ensure that the regulatory framework continues to deliver safe and effective devices, supports innovation, and addresses the needs of patients, healthcare systems, and the industry. The consultation and call for evidence are open until 21 March 2025 and can be accessed here 👉 https://lnkd.in/emHwpyxU Are you a manufacturer of medical devices or in vitro diagnostics who needs support placing products on the #SwissMarket or #EuropeanMarket? We provide hands-on regulatory guidance and the service to be your CH-REP. Contact us ☞ meetus@taoexcellence.ch #MedTech #EURegulations #Medtechindustry #regulatoryaffairs #compliance #Healthcare #Innovation #patientsafety #medicaldevicesafety #publichealth #healthcare #innovation #medicaltechnology

For manufacturers of #medicaldevices and in vitro diagnostic medical devices #IVDs in #Europe. 🇪🇺 The latest revision of #MDCG 2029-13 Rev. 1 has been released on sampling requirements applicable to Class IIa and Class IIb devices under Regulation (EU) 2017/745 #MDR and Class B and Class C devices under Regulation (EU) 2017/746 #IVDR. This revision includes an update to footnote number 10 and provides clarity regarding technical documentation assessments. The guidance emphasizes the need for a structured approach to technical documentation assessment prior to audits, aligning with Article 52(4) and (6) of the MDR, Article 48(7) and (9) of the IVDR, and the relevant sections of Annex IX and Annex XI. The document reinforces the necessity for notified bodies to develop and maintain representative sampling plans, ensuring compliance with the requirements of Annex VII. The guidance provides criteria for sampling methodologies, offering clarity on how notified bodies are expected to assess the technical documentation. It defines the responsibilities of notified bodies in the context of quality management system audits and highlights the importance of completing these assessments in due time. It also addresses specific exemptions for certain types of devices. Do you need support preparing your #Qualitymanagementsystem and completing your #technicaldocumentation or identify gaps? Reach out to us if you want to safe costs and time ☞ meetus@taoexcellence.ch #regulatoryaffairs #compliance #readiness #medtech #notifiedbodies #QMS #riskmanagement #invitrodiagnostics #medtechindustry #EU #EUCommission #publichealth #healthcare 

For Sponsors of #clinicaltrials in #Switzerland. 🇨🇭 Swissmedic has launched the public consultation on Guideline E6(R3) Annex 2 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use #ICH Guidelines. 👉 Deadline for submissions: 28 February 2025. In the past two decades, clinical trials have significantly evolved in complexity, embracing innovations in design, technology, and data collection. The proposed E6(R3) Annex 2 focuses on non-traditional interventional clinical trials, offering additional considerations on applying Good Clinical Practice (GCP) principles to diverse trial designs and data sources. It builds on the foundational work of Annex 1, providing ethical and scientific guidance adaptable to today’s rapidly changing clinical landscape. Stakeholders are invited to review the draft guideline and submit their comments via the feedback form provided by ICH. Please note that confirmation of receipt will be provided, but individual feedback will not be issued. For further details and access to the guideline and feedback form, visit the Swissmedic website or the ICH page. 👉 https://lnkd.in/dW_zSD9c Do you need support with your clinical trial design and benchmarking your #clinicaldata? Contact us for hands-on guidance. ☞ meetus@taoexcellence.ch #ClinicalTrials #GoodClinicalPractice #ICHGuidelines #Swissmedic #PublicConsultation #regulatoryaffairs #RealWorldDate #RWD #RWE #Regulatorycompliance #medicaldevices #medtech #digitalhealth #healthcare #publichealth #patientsafety

#EMA Mid-Year Report 2024: Key Developments and Achievements 🇪🇺 The European Medicines Agency has released its mid-year report for 2024, highlighting significant progress across its strategic priorities as outlined in the Single Programming Document (2024-2026). Presented to the Agency's Management Board on 3 October 2024, the report underscores advancements in regulatory innovation, stakeholder collaboration, and operational excellence. Highlights include: 🔹 Medicine Assessment: DARWIN EU expanded with 20 partners across 13 countries, initiating 12 real-world studies, while the ACT EU initiative advanced clinical trial methodologies. 🔹 One Health: EMA and EU agencies launched a One Health framework and issued the fourth joint antimicrobial resistance report with ECDC and EFSA. 🔹 Medicines Shortages: Recommendations were provided to strengthen supply chains, with a focus on critical medicines like GLP-1 receptor agonists. 🔹 Digital Transformation: EMA became the first EU agency to achieve full cloud-based operations, launching tools like the AI-powered Scientific Explorer. 🔹 Global Collaboration: Support for the African Medicines Agency continues, reinforcing global regulatory frameworks. EMA remains committed to innovation and collaboration, ensuring patient-centered, sustainable regulatory excellence. If you're seeking guidance or support in navigating the pivotal landscape of medical device development and qualification, our team is here to provide assistance. Feel free to reach out to us for support. ☞ meetus@taoexcellence.ch #regulatoryaffairs #regulatorycompliance #healthcare #healthtech #medtechindustry #clinicalevaluation #HealthcareInnovation #PublicHealth #OneHealth #AMR #ClinicalTrials #dataresearch 

For #medicaldevice manufacturers in the #US. 🇺🇸 The FDA Food and Drug Administration has published its Report on Risks and Benefits to Health of Non-Device Software Functions – December 2024. This publication highlights findings from the FDA’s Digital Health Center of Excellence on software functions excluded from the “device” definition under the 21st Century Cures Act. The report examines five software functions, ranging from tools that provide administrative support to healthcare facilities to those designed to help individuals maintain a healthy lifestyle, provided they are unrelated to the prevention or treatment of disease. The analysis incorporates insights from external experts, peer-reviewed literature, adverse event databases, and public feedback submitted through a public docket. Do you wish to place your AI / ML enabled medical devices on the US market or #Swissmarket? We support you with our hands-on services to build a proper risk management to your system. Contact us ☞ meetus@taoexcellence.ch #FDA #DigitalHealth #SoftwareInnovation #HealthTech #regulatoryaffairs #regulatorycompliance #ehealth #healthcare #publichealth #medtechindustry #healthtechnology #artificialintellingence

For manufacturers of #medicaldevices in the #EU. 🇪🇺 The European Commission has published its Report on the Implementation of Article 17 of Regulation (EU) 2017/745 on Medical Devices #MDR. This report provides critical insights into the reprocessing of single-use devices #SUDs across Europe. Key highlights from the report: 🔹 Fragmented Regulatory Landscape: Of the 30 surveyed countries (27 EU Member States, Iceland, Liechtenstein, Norway), only 10 permit the reprocessing of SUDs, often with strict national-level restrictions. 🔹 Limited Market Interest: Only six notified bodies certify reprocessed SUDs, with no certificates issued to date. Fewer than 10 manufacturers focus on SUD reprocessing, with only two active in the EU. 🔹 Stakeholder Challenges: Barriers include limited resources, liability concerns, health risks, and the lack of harmonization in regulations. 🔹 Opportunities Identified: Despite challenges, stakeholders highlight the environmental benefits, potential cost savings, and a possible solution to device shortages through reprocessing. The Commission acknowledges these challenges and will continue to assess the provisions of Article 17, exploring potential actions to address identified gaps. This report underscores the complexities of implementing a harmonized approach to SUD reprocessing while balancing innovation, safety, and sustainability. Do you need support in navigating the intricacies of all the regulations in the Medtech industry? We are here to assist you in achieving compliance with the specific requirements for medical devices and IVDs. Contact us ☞ meetus@taoexcellence.ch #RegulationEU2017 #MDR #SingleUseDevices #HealthcareInnovation #SustainabilityInHealthcare #MedicalDeviceRegulation #CircularEconomy #PatientSafety #HealthcarePolicy #EURegulations #HealthTech #SUDReprocessing #regulatoryaffairs #compliance

For #medicaldevice manufacturers in the #EU. 🇪🇺 As we approach the anticipated go-live of most #EUDAMED modules in 2025, MedTech Europe has published a position paper outlining the industry’s perspectives on achieving a seamless transition to the mandatory use of this essential European database for medical devices. EUDAMED serves as an infrastructure of the EU’s Medical Device Regulation #MDR and In Vitro Diagnostic Regulation #IVDR, and its successful implementation is critical for regulatory compliance, patient safety, and industry efficiency. MedTech Europe highlights the need to address usability challenges, provide adequate support for stakeholders, and establish clear, reliable timelines for the database’s final development phase. The paper emphasizes the importance of technical and regulatory measures to enhance accessibility, efficiency, and consistency. Industry readiness and the efficient use of resources will be central to ensuring a successful transition to EUDAMED’s mandatory use. Are you a manufacturer that needs support with the EUDAMED actor registration? We help you implement all the regulatory requirements for a fast market access. Contact us to save time ☞ meetus@taoexcellence.ch #regulatorycompliance #regulatoryaffairs #innovation #patientsafety #publichealth #healthcare #healthtech #MedicalDevices #MedTech #invitrodiagnostics #IVDs #database #datacollecting #notifiedbodies