medical vial access iso 13485 Switzerland

  • Investor Presentation May 2021

    GE Medical Systems, Johnson & Johnson, Novartis, UCB, Novo, Elan, Chiesi, CVS, Prime Therapeutics, ISO 13485 Certified Aetna, Cigna HIPAA, GDPR Compliant 1st Publicly Listed DTx Company on Euronext Growth Paris Digital therapeutic solutions helping patients manage their drug therapy Regulatory-cleared, clinically-validated solutions

  • Famar VentureRadar

    Affinity Life Sciences is a cGMP and ISO 13485 compliant company can provide custom services including in vitro diagnostic kit production, reagent formulation, vial/bulk reagent filling and labeling, kit assembly and labeling, and microplate coating of proteins, nucleic acids, cells, or other target molecules.

  • ISO 13485 SGS

    ISO 13485 2016 Medical Devices Quality Management Systems Course PDF / 266.4 KB E-learning Programs for ISO 13485 2016 PDF / 253.94 KB ISO 13485 2016 Brochure PDF / 482.23 KB New ISO 13485 2016 Medical Devices Training Course New ISO 13485 2016 Standard View Medical

  • PVC-0Perspex Vial Container

    Perspex vial container for the shielding of beta radiation used in Nuclear Medicine departmens. Members get access to our on demand and live webinars, guides, product data sheets, catalogues, exclusive videos, and more. ISO 9001 & ISO 13485 Certified Quality System. ISO 45001

  • ISO 13485 Quality Management System for Medical Devices

    ISO 13485 is similar in scope and intent to ISO 9001, but it includes additional requirements specific to medical devices while excluding certain ISO 9001 provisions. Therefore, in most jurisdictions, ISO 9001 certification is not an acceptable substitute for certification to the requirements of ISO 13485.

  • Understanding ISO 13485Certification of a Quality

    Jun 16, 2020 · It is important to understand that ISO 13485 certification is a regulatory requirement in some countries, either as prerequisite for medical device regulatory approval or for certain establishments in the medical device supply chain. Overall, ISO 13485 certification of a medical device manufacturer is expected in most countries.

  • ISO International Organization for Standardization

    ISO, the International Organization for Standardization, is a nonprofit organization that develops and publishes standards of virtually every possible sort, ranging from standards for information technology to fluid dynamics and nuclear energy. Headquartered in Geneva, Switzerland, ISO is composed of 162 members, each one the sole

  • Merit Medical OEM Medical Device Supplier Directory

    Merit Medical Systems Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures. Merit Medical serves client hospitals worldwide with a domestic and international sales force.

  • CCIT OptionsEurofins Medical Device Testing

    The Chemistry and Container Testing group at Eurofins Medical Device Testing has recently purchased a VeriPac 455-M5 vacuum decay instrument from Packaging Technologies and Inspection (PTI). This equipment can perform leak testing on container/closure systems such as syringes, vials, and pouches.

  • Complaint Handling ArchivesMedical Device Academy

    Posted by Rob Packard on March 5, 2014. Medical Device Academy performed data analysis of FDA 483s for 2013 and identified four areas of focus for your medical device complaint handling training. One of the challenges of creating a strong training curriculum is the need for practical examples.

  • ISO CertificationPromega

    ISO certification assures our global customers that Promega is committed to quality and has established reliable and effective processes. ISO certification exemplifies our commitment to our customers, to our business, and to all those who rely on and benefit from the use of our products.

  • Custom Plastic Injection Molding Solutions Comar

    That access includes full engineering support for your R&D team or your packaging design group. Part 820 and ISO 9001 and ISO 13485 for medical devices. A SOLUTION TO KEEP LIQUIDS IN THE VIAL UNDER AUTOCLAVE TEMPERATURES.


    in Switzerland with strong in-house competencies covering concept and product development, tool-making, injection moulding and automated assembly. Ypsomed is ISO 13485 certified and all processes are run according to design control and cGMP guidelines with operational QA/QC experts on-site at each location. Ypsomed’s US FDA-registered

  • ISO 7864 ISO Testing Smithers

    Standard name Sterile hypodermic needles for single useRequirements and test methods (ISO 7864 2016). Applicable medical devices This standard specifies the requirements which need to be met by sterile single-use hypodermic needles of the metric sizes 0.18 mm to 1.2 mm.

  • MDSAP and EU ISO 13485 Approach to QMS

    Most of the Regulations that govern today’s Medical Device world (EU Medical Device Directive, US FDA CFR 21-820, ISO 13485, Japan MHLW, Australia TGA, Brazil ANVISA, Health Canada, China SFDA, etc) have been created, implemented, and even revised several times during his 30-year daily industry activity in leadership QA/RA roles.

  • Global Health and Biodefense ATCC

    ATCC Federal Solutions provides government contracts for global health and biodefense capabilities including diagnostic reagents, surveillance kits, and subject experts to support the SARS-CoV-2 pandemic, other infectious and chronic disease agent characterization, and medical

  • EN ISO 13485 Certification PH TÜV Rheinland

    Medical devices (including Class I) greatly benefit from a production line, that includes an internationally recognized EN ISO 13485 certified quality management system (QMS). The certification framework provides for more product opportunities and extensive market access approval.

  • Quality Management System (QMS) ISO 13485 Certification

    ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.

  • Covidien Products Medical Surgical Portfolio Medtronic

    Covidien. Products. From advanced energy-based surgical devices to decades of experience across areas of respiratory care, we offer unmatched clinical and economic value through our range of market-leading brands. Filter By. Filter By All Products. Advanced Energy and Stapling. Gastrointestinal and Hepatology. General Surgery.

  • Certificate of Registration of Quality ICU Medical

    May 24, 2017 · feeding valves, vial access devices, infusion sets, monitoring devices and sterile leur access valve disinfectant cap. The manufacture, repair and servicing of optical modules for oxygen measurement. Irradiation sterilization of medical devices in accordance with ISO 2006.

  • Radiopharmaceutical Dispensing Isolator for Vials and

    The Phaedra Isolator. ensures high ergonomics and operative rapidity in pre-production stages (introduction of vials, syringes and disposable in the aseptic area) and post-production stages (removal of disposable and cleaning) ensures flexibility during management and extraction of final containers, either in vial format or as syringes or cartridges, thanks to the new universal extraction

  • Medical DevicesISO 13485 MTIC Group

    The new ISO 13485 2016 standard, in force since March 24, 2016 and available in the Italian version since October 26, 2016, has as its main objective to facilitate the harmonization of medical devices with the regulations of the Quality Management System.

  • ISO 13485Quality Management Systems For Medical Devices

    Life Sciences ISO 13485Quality Management Systems For Medical DevicesInternal Auditor Training The training has been designed to give you the necessary skills to perform internal audits on an organization’s Quality Management Systems (QMS) for Medical Devices to the requirements of 13485 2016 and to contribute to their continual

  • ISOISO 14971 2019Medical devices — Application of

    This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these

  • We Simplify Market Access for Medical DevicesDecomplix

    Skip steps to your CE mark and save time. Don’t worry about finding reliable CE compliance experts, working with a Notified Body or getting your company ISO 13485 certifiedwe will cover that for you. With us at your side, you already fulfill those requirements and can focus directly on getting your medical product CE marked.

  • Health Canada CMDCAS, MDSAP and ISO 13485 QMS Compliance

    Quality system compliance to the ISO 13485 standard is expected in many medical device markets it is not enough in Canada. Health Canada currently requires compliance to the Medical Device Single Audit Program (MDSAP), which includes additional QMS procedures and regulatory requirements before they will approve your device for sale.