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ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry It is designed to be used by organizations involved in multiple aspects of the industry including the servicing of medical devices It therefore applies to third party endoscope repair companies
Jun 28 2017 ISO 13485 2016 identifies the purpose of infrastructure as being to achieve conformity to product requirements The standard specifies infrastructure as 1 Buildings workspaces and associated utilitiesThis includes the building that provides the area for manufacturing of products and ultimately storage
Dec 07 2020 Top Clean Injection is ISO 13485 certified This company is also a medical device manufacturer Top Clean Injection supports customers from the conception of the medical device to its sterilization in the packaging Additional services Product design tool making workshop Sterilization of medical devices by the STERRAD process
Embosphere Microspheres the most clinically studied round embolic provide consistent and predictable results for effective embolisation in the treatment of uterine fibroids hypervascular tumours or arteriovenous malformations Used in over 250 000 procedures to date Embosphere Microspheres are the Gold Standard in uterine fibroid embolisation with Interventional Radiologists choosing
ISO Class 8 cleanrooms Twinsburg Ohio 1700 Highland Rd Twinsburg OH 44087 11 000 sq ft Facilityall Class 8 cleanroom space 70 Team members ISO 14001 ISO 13485 certified and FDA registered 23 Molding presses 3 Production extruders
Fresenius Medical Care is the world s leading provider of products and services for individuals with renal diseases of which around 3 7 million patients worldwide regularly undergo dialysis treatment Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers
Submit reports to the FDA through the MedWatch program in one of the following ways Complete the MedWatch Online Reporting Form Download form or call to request a reporting form
With Boyd s ISO 13485 certifications you can be sure that we are bringing the best quality standards to your medical products Boyd s ISO 13485 facilities take ISO 9001 quality controls to the next level with more thorough documentation and stricter process controls Boyd adheres to ISO 13485 through each step of our solutions life
Brochures Instructions for Use ISO 13485 Certification English Brochures Advocate PTA Catheter AERO Tracheobronchial Patient Card US A S K Merit Access Safety Kit Instructions For Use Merit Medical Hemostasis Valve Adapter Instructions For Use Multi Lingual
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 auditing processes
Sterigenics is a global leader in comprehensive sterilization services industrial sterilization needs across the medical device pharmaceutical advanced applications commercial and food industries when and where you need us commercialization to ensure the safety of your product and your process
1040 Sheridan Street Chicopee MA 01022 United States Facility Highlights 76 000 sq ft Class 8 clean room white room 41 molding presses 3 tons1 000 tons including 10 micromolding slide machines ISO 13485 certified ISO 9001
Become ISO 13485 certified under accreditation with AFNOR Group a leading certification body for more than 20 years ISO 13485 regulatory system certification is recognized by all professionals in the medical device industry from design to dismantling including distribution and maintenance
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
Jun 16 2020 Implement your quality system one bite at a time Task 1Purchase applicable standards The first task in implementing an ISO 13485 quality system is to purchase a copy of the ISO 13485 2016 standard such as the MDSAP Companion Document You will also need other applicable medical device standards
Planning the implementation of ISO 13485 2016 is a crucial step in the success of your Medical Device Management System With our ISO 13485 2016 Implementation Diagram you can see at a glance the step by step process to follow ensuring nothing is forgotten
ISO 13485 Design and Manufacture of Medical Devices ISO 13485 is a quality management system standard designed for medical device companies Being ISO 13485 Certificatio n compliant shows a commitment to the safety and quality of your medical devices Establish a risk based approach to product development and realization
Jul 13 2021 ISO 13485 2016 is an internationally recognized quality standard to ensure the consistent design development production installation and sale of medical devices that are safe for their
Feb 05 2020 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
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
Jun 19 2020 Benefits resulting from the cooperation with a contract manufacturing service provider of medical devices holding the ISO 13485 certificate Deciding for an EMS provider to produce medical devices you can expect evident benefits in case of companies possessing the ISO 13485
Jul 26 2021 ISO 13485 Certification in Dubai is the international organization for Standardization ISO that provides needs for quality management systems QMS of companies concerned within the medical device business This customary relies on the internationally recognized ISO 9001 QMS standard which isn t specific to any industry or form of product and incorporates extra elements relevant to medical
Since the publication of ISO 13485 2016 risk management is a major concern for maintaining regulatory compliance in major medical device markets read more Preparing to Change your European Notified Body The transition deadline for the European Medical Devices Regulation MDR 2017/745 will be here soon and medical device companies are
Become ISO 13485 certified under accreditation with AFNOR Group a leading certification body for more than 20 years ISO 13485 regulatory system certification is recognized by all professionals in the medical device industry from design to dismantling including distribution and maintenance
MDSAP Certificate ISO 13485 2016 K BIOARRAY MD Certificate EN ISO 13485 2016 K BIOARRAY SX Dominion Biologicals Limited Dartmouth Canada EC Certificate Annex II List A Products K DOMINION EC CERT HL EC Design Examination Certificate Rhesus Blood Grouping
Over the past year Yukon Medical has launched six new vial access devices that provide a safe way to accurately prepare injectable medications These products were designed to be easy to use eliminate needles minimize residual volume increase attachment security to the vial and minimize exposure to vapors and leaks explains Todd
Yukon Medical A division of Borla Yukon Medical is an ISO 13485 certified and leading developer of innovative pharmaceutical preparation and delivery devices with a focus on reconstitution at the point of care and injectable drug delivery
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
Mar 30 2017 All new ISO 13485 customers will automatically be certified under ISO 13485 2016 With the SCC accreditation UL qualified staff can begin to audit to ISO 13485 2016 and issue certificates ISO 13485 concepts are part of most Regulatory QMS requirements including the new Medical Device Single Audit Program MDSAP for which UL is an Authorized
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
Jul 19 2013 Yukon Medical has also obtained a certificate for CE Marking its ViaLok Vented Vial Access Devices Achieving ISO 13485 certification is a major milestone for Yukon Medical
Dec 15 2020 Our global product portfolio enables clinicians to be more efficient and effective in treating patients at the hospital bedside in the operating theater in critical care units at home and in the dialysis clinic We are working alongside our partners to find new and smarter ways to improve patient outcomes prevent complications before they become life threatening and increase access to care
ISO 13485 Quality Management System The ISO 13485 2016 is a useful standard because it specifies requirements for a quality management system QMS when an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements
Dec 15 2020 Our global product portfolio enables clinicians to be more efficient and effective in treating patients at the hospital bedside in the operating theater in critical care units at home and in the dialysis clinic We are working alongside our partners to find new and smarter ways to improve patient outcomes prevent complications before they become life threatening and increase access to care
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