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

FDA Guidance Update: Explore the latest FDA guidance on ‘Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA. This document provides essential information for industry professionals to navigate regulatory requirements effectively. #FDA #GDUFA #RegulatoryAffairs

Supporting Med-tech Start-ups Start-ups face unique challenges in the medical device industry. Discover how TS Quality & Engineering helps new ventures ensure safety, efficacy, and regulatory compliance from the outset. #Startups #MedTech #RegulatoryCompliance #Innovation Read more: TS Q&E Helping Med-tech Start-ups from the Ground to Succeed

This is a self-paced course on the design and development of medical devices as per ISO 13485:2016 and best practices in the medical devices sector. ISO 13485:2016 is the recognized global standard for the quality management system (QMS) of medical devices manufacturers and suppliers. The standard name is also prescribed with the supporting expression ""For Regulatory Purposes"". It means the standard is developed to assist organizations in complying with the regulatory requirements as well. The design and development process in a QMS is the most complex part. Likewise in the medical devices sector, design and development is a complicated process that incorporates numerous roles and phases. Therefore this course is designed to adapt the process of design and development of medical devices easier for delegates to learn. In this session, the rising model based on ISO 13485:2016 requirements of design and development is discussed. The rising model is developed by the Trainer himself and is, therefore, a unique way of explaining the ISO 13485 requirements on design and development. This is in contrast with the FDA waterfall model. Who should take this self-paced course? - Employees in the field of Quality Management who are new in the medical devices sector - Any professional who is working or opts to work in the Research and Development of a company producing medical devices - Product development persons in the medical devices industry - Medical engineers who opt to work in this industry - Employees looking to learn ISO 13485:2016 - Any individual who opts to work and make a career in the medical devices industry. What delegates will learn in this course? - Brief detail about #ISO13485:2016 standard - What is the ""design and development"" process of a medical device? - What are the phases of ""design and development"" for a medical device? - How to manage the ""design and development"" in a life-cycle of medical devices? - FDA Waterfall model for design and development - Unique rising model for design and development developed as per ISO 13485. Registration Link: https://lnkd.in/fAk4GWh #medicaldevices #fda #quality #designcontrol #design Original Post Link: https://lnkd.in/eDr9mRAg

Biocompatibility Testing of Medical Devices Document This document outlines the critical role of biocompatibility testing in medical device development. It highlights regulatory expectations and best practices to ensure that materials used in devices do not cause adverse biological reactions. #Biocompatibility #MedicalDevices #RegulatoryCompliance #QualityAssurance

MDCG 2021-25 Rev.1 Guidance Document This document outlines the application of MDR requirements to legacy devices and those placed on the market before May 26, 2021. It provides clarity on how manufacturers should comply with the updated regulations for these devices, ensuring ongoing safety and performance in the market. This guidance is essential for anyone involved in managing legacy devices within the medical device landscape. #MDCG #MDR #MedicalDevice #LegacyDevices #MedicalConsulting

📚🌐🔬 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