TS Quality & Engineering Viale Tripoli 53 - 47921 Rimini - Rimini Telefono: 05411797426 | Fax: 05411797423 Partita IVA: 03983530407 http://www.reteimprese.it/83049 it-IT Tue, 28 Jul 2026 16:49:53 +0200 Tue, 28 Jul 2026 16:49:53 +0200 http://blogs.law.harvard.edu/tech/rss Reteimprese publishing script http://www.reteimprese.it/pro_A83049B330731 Tue, 28 Jul 2026 16:49:53 +0200 http://www.reteimprese.it/pro_A83049B330731 ISO 13485:2016 – Transition Training - Recorded Webinar - [ITALIANO] Description: This recorded webinar course will provide guidance on how to perform the transition to the Medical Device Quality Management System (QMS) Standard ISO 13485:2016 . In Particular will discuss the following points: 1. Comparison with previous version of ISO 13485 2. Impact on existing QMS 3. Consistency with new ISO 9001:2015 4. Regulatory impact The new ISO 13485:2016 standard provides an effective framework to meet the comprehensive requirements for a medical devices quality management system ; for manufacturers and service providers to both comply and demonstrate their compliance to regulatory requirements. ISO 13485:2016 supports the design of a quality management system that establishes and maintains the effectiveness of a manufacturer’s processes to ensure the consistent design, development, production, installation, and delivery of medical devices, or related services, that are safe for their intended purpose. The new edition is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device. Why Should You Attend: Transition time has started! ISO 13485:2003/2012 and ISO 13485:2016 are now coexisting, start implementing the changes to your Quality Management System will make you ready for the switch . Some of the biggest changes between the 2003/2012 and 2016 version include: Application of risk-based approaches in the 2016 standard now extend beyond product realization processes alone. ; Increased linkage with regulatory requirements , particularly for regulatory documentation; Application to organizations throughout the lifecycle and supply chain for medical devices; Harmonization of the requirements for software validation for different software applications. In previous versions of ISO 13485, this has not been as clear as it needed to be. Software validation and on-going functional verification of software are now equally importance across the standard. Emphasis on appropriate infrastructure, particularly for production of sterile medical devices, and addition of requirements for validation of sterile barrier properties. Additional requirements in design and development on consideration of usability. Emphasis on complaint handling and reporting to regulatory authorities Planning and documenting corrective action and preventive action Who Will Benefit: Quality Manager Quality Engineers Design Quality Regulatory Affairs specialist Medical Affairs specialist Clinical Affair specialist R&D Engineers Marketing Certification Requirements: Students must view the entire program and successfully pass an online, multiple choice final assessment with > 80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements. Online Training Programs Includes: Answer to questions submitted during the webinar. An online final assessment with multiple choice questions. A Certificate of Completion. 5 Months Access to the recorded session EUR 175.00 September 26, 2026 ]]> Medical Device Webinar http://www.reteimprese.it/pro_A83049B330730 Tue, 28 Jul 2026 16:49:53 +0200 http://www.reteimprese.it/pro_A83049B330730 Medical Device Sterilization Process: ETO, GAMMA, STEAM, SHELF Life, Validation - On Demand Live Webinar - [ITALIANO] Description: Sterilization results in destruction of all forms of microbial life, while disinfection results in destruction of specific pathogenic microorganisms . Because disinfection is faster and less expensive, some hospitals substitute highlevel disinfection for sterilization of medical instruments. An object should be disinfected or sterilized depending on its intended use . This live webinar course will provides guidance on medical device sterilization processes. In Particular will discuss the following points: Definition of Sterility Main methods : EtO , gamma , steam Maintaining the sterility and shelf life Why Should You Attend: “Sterilization means the use of a physical or chemical procedure to destroy all microbial life, including highly resistant bacterial endospores.” Bacterial spores are the most resistant of all living organisms because their capability to withstand destructive agents. Although the chemical or physical process used to destroy all pathogenic microorganisms including spores is not absolute, when all parameters of the sterilization process have been met, instruments, supplies and equipment are thought to be sterile. Critical objects (those that enter sterile tissues or the vascular system or through which blood flows, such as implanted medical devices) require sterilization before use. Items that touch mucous membranes or nonintact skin, like endoscopes, respiratory therapy equipment, and diaphragms, require high-level disinfection. Sterilization falls into the following three categories: • High temperature/pressure sterilization (autoclave) • Chemical sterilization • Radiation sterilization . Who Will Benefit: Sterility Assurance Manufacturing Quality Control Quality Manager Quality Engineer Regulatory Affairs specialist R&D Engineer Pharmaceutical Engineer Validation Engineer Process Engineer Certification Requirements: Students must view the entire program and successfully pass an online, multiple choice final assessment with > 80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements. Online Training Programs Includes: Answer to questions submitted during the webinar. An online final assessment with multiple choice questions. A Certificate of Completion. Live Course Presented and Commented by: Alice Ravizza is a Biomedical Engineer, graduated at Politecnico di Milano. She has great and extensive experience in R&D and QA / RA in the biomedical field. She is specialized in supporting Medical Device companies in building up and improve Quality System Management and assure Compliance through all the internal processs. She assist companies during the registration process for CE Mark making sure all the technical documentation is compliant to applicable standards and regulations. She is aswell an experienced Trainer and Lecturer. EUR 185.00 September 26, 2026 ]]> Medical Device Webinar http://www.reteimprese.it/pro_A83049B330729 Tue, 28 Jul 2026 16:49:53 +0200 http://www.reteimprese.it/pro_A83049B330729 Biological Safety Evaluation ISO 10993 - Risk Approach - In Vivo - In Vitro Test - Technical File - On Demand Live Webinar - [ITALIANO] This live webinar course will provides guidance on biological safety evaluation and ISO 10993:2009. In Particular will discuss the following points: ISO 10993:2009 Biological Safety Evaluation Risk Approach In Vitro Test In Vivo Test Biological Safety Evaluation and Technical File Why Should You Attend: A medical device or material that comes in contact with the patient's body is expected to perform its intended function without resulting in any adverse effect to a patient. Potential adverse effects can range from short-term (acute) to long-term (chronic) adverse effects to the body such as mutagenic effects. For this reason, medical devices are typically subject to biological evaluation and biocompatibility testing to assess the interaction between a device and tissue, cells or body fluids of the patient. Biocompatibility testing answers two fundamental questions: Is the material safe? Does it have the necessary physical and mechanical properties for its proposed function? Who Will Benefit: Manufacturing Quality Control Quality Manager Quality Engineer Regulatory Affairs specialist R&D Engineer Pharmaceutical Engineer Validation Engineer Process Engineer EUR 185.00 September 26, 2026 ]]> Medical Device Webinar http://www.reteimprese.it/pro_A83049B330728 Tue, 28 Jul 2026 16:49:53 +0200 http://www.reteimprese.it/pro_A83049B330728 Camera Bianca : Nuova ISO 14644, design and construction, proof of continuous compliance, personnel behaviour - [ITA] - Recorded Live Webinar - Descrizione: Controllare la contaminazione è essenziale in molte attività di produzione e di ricerca. L'uso di camere bianche, insieme a processi rigorosi e stringenti, lo rende possibile. ISO ha una serie di norme dedicate alle camere bianche, che delineano le pratiche e le procedure necessarie per gestire il rischio di contaminazione. I primi due nella serie sono stati appena aggiornati per tener conto dei più recenti sviluppi tecnologici e dellle esigenze del mercato. Questa corso webinar registrato fornisce le linee guida sulle camere bianche con particolare riferimento allo standard. ISO 14644: 2015. In particolare si discuterà i seguenti punti: Nuova norma ISO 14644: 2015 Design e Costruzione di una Camera Bianca Mantenimento della conformità continua Comportamento del personale Why Should You Attend: A cleanroom or clean room is an environment, typically used in manufacturing, including of pharmaceutical products or scientific research, with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. Food production, pharmaceuticals, aerospace and automotive manufacturing are just some of the many areas where controlled and classified clean rooms are essential. Clean rooms are zones where contaminants in the air are highly controlled. Without effective control, contamination can wreak havoc on products and processes. ISO has a series of standards dedicated to clean rooms , outlining the practices and procedures required to manage the risk of contamination. The first two in the series have just been updated to take into account the latest technological developments and market requirements. ISO 14644-1:2015, Clean rooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration , and ISO 14644-2:2015, Clean rooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration , provide the framework for classifying and monitoring the cleanliness of the air in cleanrooms. ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones ; and separative devices as defined in ISO 14644‑7.Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0, 1 µm to 5 µm are considered for classification purposes. The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling locations. ISO 14644-1:2015 does not provide for classification of particle populations that are outside the specified lower threshold particle-size range, 0, 1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0, 1 µm) will be addressed in a separate standard to specify air cleanliness by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 µm). ISO 14644-1:2015 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles. ISO 14644-2:2015 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration. ISO 14644-2:2015 does not address condition monitoring of aspects such as vibration or general maintenance of the engineering systems. It does not provide for monitoring of particle populations that are outside the specified lower threshold particle-size range, 0, 1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0, 1µm) will be addressed in a separate standard. EUR 155.00 September 26, 2026 ]]> Medical Device Webinar http://www.reteimprese.it/pro_A83049B330727 Tue, 28 Jul 2026 16:49:53 +0200 http://www.reteimprese.it/pro_A83049B330727 Nuovo Regolamento Dispositivi Medici Aggiornamento 2016 - Live Webinar - [ITALIANO] Descrizione: Questo live webinar course vi guiderà all'interno dei nuovi requisiti introdotti dall'aggiornamento 2016 del regolamento comunitario sui dispositivi medici: In Particolare affronterà i seguenti punti: Principali nuovi requisiti (UDI) Unique Identification number Post market activities Nuovo Technical File Transizione dal regolamento vigente al nuovo regolamento A chi è rivolto il Corso : Quality Manager Quality Engineers Design Quality Regulatory Affairs specialist Medical Affairs specialist Clinical Affair specialist R&D Engineers Marketing Requisiti per il rilascio dell'attestato: Il partecipante deve assistere all'intero corso e deve superare con esito positivo un test finale. Il certificato verrà rilasciato con un punteggio conseguito superiore all'80%. Il certificato firmato dal trainer verrà spedito via email e se richiesto anche via posta. Il programma Online include: Risposte alle domande effettuate durante il live Webinar. Un quiz finale Il rilascio di un certificato firmato dal trainer. EUR 175.00 September 26, 2026 ]]> Medical Device Webinar