TS Quality & Engineering

Great time at Biomedical Valley AI Workshop TS Quality & Engineering is once more proud to be Sponsor of BiomedicalValley2024! Nice chance to meet new and old partners and talk about new challenges and opportunities for MedTech industry!! Special thanks goes to: Alberto Casoni, Senanur Akkılıç Giampaolo Rimondi Marco Fecondini for the nice discussion around the table and to Gianluca Tordi, MsC, EMBA and Francesco Bardelli for attending the event and the nice discussion and presentations! Thanks also to Matteo Stefanini for the great organization of the event ..like always !!💪💪 #biomedicalvalley #tsquality #innovation #onehealth #consulting #ai #networking #cooperation #community

📚🌐🔬 At TS Quality & Engineering, we provide a comprehensive suite of services tailored to cater to your unique needs in the Medical Device field. 1️⃣ MDR Consulting Service: We offer expert guidance to navigate the complexities of the Medical Device Regulation (MDR) landscape. 2️⃣ EU Authorized Representative: We act as your reliable liaison in the European Union, ensuring your compliance with EU regulatory requirements. 3️⃣ SAR Swiss Authorized Representative: As your trusted representative in Switzerland, we help you comply with Swiss regulatory standards. 4️⃣ EU PRRC: Our Person Responsible for Regulatory Compliance (PRRC) service ensures your products meet and maintain all EU regulatory standards. 5️⃣ Design Control Process: We assist in the systematic management of your design process to guarantee product quality and safety. 6️⃣ DHF Design History File: Our team manages and maintains your DHF, ensuring your device design is consistently compliant. 7️⃣ Technical File Design Dossier: We aid in compiling a complete design dossier for your medical device, helping you get your product to market faster. 8️⃣ Risk Management Process: We adopt a proactive approach to identify, evaluate, and control risks associated with your medical device. 9️⃣ Clinical Evaluation: Our expert team conducts thorough clinical evaluations to assess the clinical safety and performance of your device. 🔟 EUDAMED Support: We offer comprehensive support for the European Database on Medical Devices (EUDAMED), ensuring your data management aligns with EU requirements. 1️⃣1️⃣ ISO 13485 Support: We provide guidance on the implementation of the ISO 13485 standard, helping you maintain a quality management system that consistently meets regulatory requirements. Our team is ready to assist you in achieving regulatory compliance and optimizing your product development process. Reach out to us today and let's start a conversation on how we can support your medical device journey! #TSQualityAndEngineering #MedicalDevices #RegulatoryCompliance #QualityManagement #ISO13485 #EUDAMED #MDR

MedTech Letter to the Commission Document This document is a letter from MedTech professionals to the European Commission, addressing current regulatory challenges and offering recommendations for improvement. It emphasizes the need for adaptable regulations that support innovation while ensuring patient safety. #MedTech #RegulatoryChallenges #EuropeanCommission #Advocacy

FDA Clinical Trials and Investigational Device Exemption (IDE) 🔬 Dive into the importance of clinical trials for developing new medical treatments and therapies, ensuring safety and effectiveness before reaching patients. Read more: https://lnkd.in/gEeFuemi #FDA #ClinicalTrials #MedicalResearch

MDPharma Courses present a premium course on #ISO14001 #environmentalmanagement system. This is a recorded course on environmental management systems as per ISO 14001:2015 and best practices for managing environmental performance. ISO 14001:2015 is the recognized global standard for the environmental management system (EMS) for companies, businesses, and manufacturing units. The standard is developed to assist organizations in complying with the environmental regulatory requirements as well. Managing environment performance in a business is the most complex part. Likewise in business excellence, this part cannot be ignored even if it is a complicated process that incorporates numerous roles and phases. Therefore this course is designed to help students understand the new ISO 14001:2015 standard and to help companies to manage and optimize their environmental performance and to improve continually. In this recorded session, the all main clauses of ISO 14001:2015 are well discussed. Along with that several activity items are also incorporated to help students understand the context of the environment, environmental audits, Emergency Preparedness & Response and Operation Controls, etc. Register for this course here: https://lnkd.in/gRuDvCE #iso140012015ems #trainingonline #course #manufacturing

BSI MDR Annex XVI QA Document This document discusses quality assurance requirements related to Annex XVI of the MDR, providing manufacturers with guidance to ensure compliance with safety and effectiveness standards for their devices. #MDR #QualityAssurance #MedicalDeviceManufacturing #Compliance

IMDRF Common Data Set for Adverse Events Document This document summarizes the IMDRF initiative aimed at standardizing adverse event reporting across jurisdictions. It emphasizes the importance of consistent data collection to enhance patient safety. #AdverseEvents #IMDRF #PatientSafety #Standardization

📢 New EMA Concept Paper: Clinical Evaluation of Therapeutic Radiopharmaceuticals in Oncology 📢 The European Medicines Agency (EMA) has released a concept paper on the clinical evaluation of therapeutic radiopharmaceuticals in oncology. This paper aims to address specific aspects of therapeutic radiopharmaceuticals (tRPs) to complement the existing guidelines on anticancer medicinal products. #EMA #Oncology #Radiopharmaceuticals #ClinicalEvaluation #Theranostics #MedicalResearch

Innovating Medical Devices with TS Q&E TS Quality & Engineering supports the development of next-gen medical devices. With a team of seasoned experts, we're here to help your innovations succeed. #MedicalDevices #Innovation #Healthcare #Engineering Read more: Accelerating Innovation in Medical Devices

👋 Meet Andrew Pacey, Our UK Cluster Lead! Andrew Pacey brings 40 years of experience in the medical device industry to our team. As a seasoned professional, he has been at the forefront of medical device realization and invention. His expertise spans the entire product lifecycle, from identifying clinical needs to global release and even corporate exits. Andrew has successfully navigated the regulatory landscape, including Class III, Class I and similar transitions, UK PRRC, FDA, and ROW registrations. 🌟 Key Highlights: • Medical Device Realization: Andrew’s expertise lies in translating unmet clinical needs into innovative medical devices. His journey starts from a blank sheet and extends all the way to product launch. • Global Impact: He has led projects with international reach, collaborating across borders to deliver cutting-edge solutions. • Supply Chain and Clinical: Andrew’s holistic approach includes setting up manufacturing processes, optimizing supply chains, and ensuring successful clinical trials. 📧 Connect with Andrew: Feel free to reach out to us at info@tsquality.it to discuss exciting opportunities, collaborations, or to learn from his wealth of experience. #MedTechInnovation #MedicalDeviceDesign #HealthcareInnovation #ClinicalNeeds #RegulatoryCompliance #SupplyChainManagement #GlobalImpact #LifeCycleManagement #MedicalDeviceRealization #Inventor "#AndrewPacey #UKClusterLead #MedicalDeviceIndustry #ExperienceinHealthcare #ProductLifecycle #RegulatoryExpert #GlobalCollaboration #InnovativeSolutions #ManufacturingProcesses #ClinicalTrials #ExpertiseinMedTech #Collaborations #HealthcareSolutions #MedicalInnovation #SupplyChainOptimization #MedicalDeviceInventor