OpSens OptoWire is a modern pressure guidewire designed to assess stenoses in vessels such as coronary arteries. OptoWire is powered by Fidela™, a patented 2 nd generation fiber optic sensor to measure physiologic indices including Fractional Flow Reserve (FFR and diastolic Pressure Ratio (dPR).
ISO certification and compliance — ISO regulations govern processes and outputs across numerous industries, including the medical industry. At a minimum, a facility producing medical components must meet ISO 13485 2003 standards with further compliance to Class I, II or III required, depending on the products being manufactured.
ISO-13485 certified facility Operation Contract manufacturing, custom injection molding, secondary operations in a cell environment, class 10,000 clean room molding and assembly Products Consumer, health care and medical devices. Brazil. Sao Paulo. West Pharmaceutical Services Brasil Ltda. Av. Nossa Senhora das Gracas, 115 Bairro Serraria
· ISO 13485 2003 Quality System Standard ISO 13485 2012 Medical Devices Quality Management Systems ISO 14155 Clinical investigation of medical devices for human subjects. ISO 14971 2012 Risk Management ISO 2009 Part 6 Evaluations of Medical Devices SOR/ 98-282 GD 207 & GD 210 Canadian MDR Quality Systems
· The revised ISO 13485 was published on 1 March 2016. IAF Resolution details a transition period of three years from the date of publication. Certification bodies have to apply to transition its accreditation. Once approved, CBs can issue certificates to ISO 13485 2016. In the interim, CBs are able to conduct audits, provided auditors are
Qualifications ISO 13485, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows Overview An end-to-end solutions provider, Tegra Medical offers contract manufacturing, from prototyping to production of complex components and finished devices, as well as full finishing, assembly and
· ISO 13485 is a quality management standard for medical devices. ISO 14971 is a global risk management standard for medical devices. AS9100D is a quality standard for aviation, space, and defense. ISO 9001 is an international quality management standard. ISO 14001 is a global environmental management standard.
As the global COVID-19 pandemic continues to challenge the delivery of healthcare worldwide, ICU Medical is committed to working with our customers to ensure you have the IV solutions, systems, and consumables you need to provide essential care. Because evolving protocols and variations in care shouldn't mean fluctuations in supply, ICU Medical
a Healthier World. For 72 years, delivering health and well-being has been our top priority. Our expertise in high-quality plastic molding for the healthcare industry has made us a trusted partner for developing and manufacturing medical devices, specialty rigid packaging, and liquid dosing and dispensing systems.
· Our commitment to manufacturing the most reliable instruments and to offering the best services was formalised with the completion of the ISO 9001 and ISO 13485 Quality Management System certifications. Product lines used in the In Vitro Diagnostics fields conform to the IVD 98/79 EEC directive for medical devices and are CE certified accordingly.
EPSIMED is a leading OEM Manufacturer and Distributor of world-class medical equipment. Our products are manufactured under international standards such as CE, ISO 13485 and ISO 9001. These standards assure quality, safety and reliability on everything we offer.
· Certifying your quality management system to ISO 13485 increases your organization's access to both U.S. and international markets. For example, ISO 13485 certification meets Good Manufacturing Practice compliance in the United States. NSF-ISR certifies any organization that manufactures medical devices, including unfinished implantable medical
2 days ago · 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
· Mandatory Medical Device Reporting Requirements The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for
Qosina is a leading global supplier of OEM single-use components for the medical and pharmaceutical industries. We help get your innovations to market with over 5,000 components in stock at our 95,000-square-foot ISO 13485, ISO 22301, ISO 9001 and ISO 14001 registered climate-controlled facility with a Class 8 Clean Room.
· Rex Medical specializes in the development, manufacturing and marketing of innovative, minimally invasive medical devices targeted towards the cardiovascular, venous access, endosurgery and oncology markets to address unmet clinical needs
· Yukon Medical is a leading developer of innovative pharmaceutical preparation and drug delivery devices. Yukon Medical was founded in 2008 with the mission to provide clinicians with safe, innovative devices for disease detection and medication preparation and administration. Since our inception, we have worked directly with clinicians and
ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the previous version of ISO 9001, ISO 9000 2008 process-based model for a regulated medical device manufacturing environment.
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their
Elcam Medical is a world class producer of disposable medical devices and components for the OEM market, and a provider of innovative solutions for specialized flow control needs.
Human Factors for Medical Devices (Sept21) September 8 to 10, 2021. Register. EUROPE Integrating Risk Management into the Product Life Cycle (Sep21) September 13 to 15, 2021. Register. Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485
· ISO 13485 2016 is making the medical sector safe for all businesses within the supply chain and, ultimately, for the end consumer, i.e., the patient. So, with all these additional requirements, organizations can prove their excellence in the eyes of customers
Aseptic Medical Devices. Newmarket Drive, Derby DE24 8SW 44 (0) 1332 755622. [email protected]
· Merit Medical is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit has made it a priority to understand customers, innovate, and deliver life-changing products and services.
The MDR and IVDR represent significant changes to European legislation for medical devices and in vitro diagnostic medical devices (IVDs). One significant new requirement is that manufacturers and authorized representatives for both medical devices and IVDs appoint at least one person responsible for regulatory compliance with responsibilities that cover the quality management system (QMS
· All medical device manufacturers are required to use a quality system certificate, ISO 13485 2003, as evidence of compliance to regulatory quality systems • Class II Medical devices must be manufactured according to this standard • Class III & IV Medical devices must be designed and manufactured according to this standard 30
· ISO 13485 2016 Medical Devices. ISO 13485 is designed for use throughout the life cycle of a medical device. It supports each stage of medical device development and operation from initial concept to production and disposal. The standard helps internal
Your Global Testing Partner. With >20 laboratories in North America, Europe and Asia Pacific, Eurofins Medical Device Testing offers regulatory compliance expertise and experienced GMP/GLP/ISO 17025 testing to ensure rapid turnaround times with the highest level of service, and most advanced technologies for your analytical chemical, microbiological, biocompatibility, electrical, mechanical
· ISO 13485 2016 audit checklists to identify gaps in your organization’s QMS and prepare for certification (1) ISO 13485 Audit Checklist (2) ISO 13485 2016 Standard Checklist (3) Collection of Quality Audits. Achieve ISO 13485 certification and maintain the quality of medical devices.
ISO 9001 Quality Management ISO 13485 Quality Management ISO 14001 Environmental Management ISO 45001 Occupational Health & Safety ISO/IEC 27001 Information Security ISO 50001 Energy Management View all standards >> Our services. Certification Compliance tools and software Developing new standards Events and conferences Product
· Predictable, Flow-Directed Targeting. QuadraSphere® Microspheres are calibrated, hydrophilic and compress up to 80% to facilitate smooth microcatheter delivery. Once through the microcatheter, they rebound to their stated spherical shape with a consistent cross-sectional diameter for predictable, flow-directed targeting.
HungaroTrial is a Full Service CRO for Medical Devices, including Clinical Trials, Regulatory Service and Market Access Service for EU market. For more information click on htdevice
TÜV SÜD’s global team of over 700 healthcare and medical device experts, engineers and medical doctors are well positioned to help the sector navigate through these uncertain times. Find out more about the services we provide for the healthcare industry and medical device manufacturers. Medical Device Market Approval & Certification.
Aseptic Medical Devices offer a standard range of BD syringes, selected for their suitability for gamma sterilisation and compatibility with existing manufacturing procedures. The whole range of products is CE marked and certified under ISO13485.
The MDR and IVDR represent significant changes to European legislation for medical devices and in vitro diagnostic medical devices (IVDs). One significant new requirement is that manufacturers and authorized representatives for both medical devices and IVDs appoint at least one person responsible for regulatory compliance with responsibilities that cover the quality management system (QMS
a Healthier World. For 72 years, delivering health and well-being has been our top priority. Our expertise in high-quality plastic molding for the healthcare industry has made us a trusted partner for developing and manufacturing medical devices, specialty rigid packaging, and liquid dosing and dispensing systems.
Certificates. The strengths of POLYMED lie in its know-how and perfected technologies. We make user-friendly products by combining the new with the tried-and-tested. Two factors are of outright importance here safety and quality. We have adopted several significant external benchmarks and certifications. The Company has been accredited with
BQ+ Medical not only produce components for manufacturers all over the world, but also provide private label manufacturing for leading brand distributors in different countries.
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