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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
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
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
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
Qosina is a leading global supplier of over 5 000 OEM components to the medical and pharmaceutical industries We operate in a 95 000 square foot facility that is ISO 13485 ISO 22301 ISO 9001 and ISO 14001 registered and includes a Class 8 Clean Room We support your team s innovation with low minimum orders and short lead times on plastic
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
Sep 18 2019 Ironstone Product Development IPD is an ISO 13485 2016 certified medical device development company They assist clients with all aspects of medical and health product development and commercialization IPD s team members have successfully commercialized dozens of innovative medical and healthcare products
Mar 12 2021 We are now preparing to obtain MDSAP certificates for all ISO 13485/CMDCAS locations when MDSAP becomes fully operational in 2017 Foods and Medical Devices Colombia
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
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
Beckman Coulter Diagnostics helps healthcare professionals provide better patient care by delivering the accurate diagnostic information they need
Since 1900 Thomas Scientific has been providing the latest in laboratory supplies laboratory equipment laboratory instruments laboratory chemicals and laboratory safety to the science community
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
Products Medical Components and Medical Equipments by following the guide institutions and publications in this field All the products are designed and manufactured to meet the requirements of relevant International Standarts ISO 13485 2016 ISO 14971 2012 ISO 80369 2017 ISO 11135 2014 ISO 2014 ISO 2014 ISO 2009
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
HMD s primary international markets are USA Europe and Middle East All its ICMED Certified Products are manufactured as per ISO 13485 and in Compliance with the European CE US FDA Regulatory requirements HMD founded in 2nd August 1957 was created to serve the Medical profession with affordable World Class Medical Devices
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
Colombia k ə ˈ l ʌ m b i ə kə LUM bee ə ˈ l ɒ m LOM Spanish officially the Republic of Colombia is a country in South America is bounded on the north by the Caribbean Sea the northwest by Panama the south by Ecuador and Peru the east by Venezuela the southeast by Brazil and the west by the Pacific Ocean lombia is composed of 32 departments and the
Diagnostic and Interventional Catheters Access Devices 6550 Wedgwood Road North Suite 300 Maple Grove Minnesota 55311 USA Phone Fax The Maple Grove facility has ISO 13485 and ISO 9001 certifications and is registered with the FDA EPIC Medtec Center for catheters and access devices
Feb 26 2019 ISO 13485 sets out the criteria for medical device quality management systems It can be used by medical devices manufacturers suppliers or any organization that can benefit in implementing the standard The recently revised standard is based on a number of quality management principles focusing on how companies should manage risk based
Access Bio s mission is to improve the lives and well being of people around the world Through the development of in vitro diagnostics technology Access Bio has successfully commercialized the highest quality products to battle malaria and other serious diseases We are a trusted partner to international public health agencies and organizations including the World Health Organization
CE Marking Medical Device Consultants ISO 13485 Consultants Medical Device Registration in Australia Medical Device Registration New Zealand EC REP services
Relationship between Ordinance #169 and ISO 13485 Japan has largely embraced ISO 13485 as the basis for their QMS requirements The PMD Act introduced a more harmonized approach to quality regulations for medical device manufacturers However Ministerial Ordinance #169 contains additional QMS requirements you must meet to be in full compliance
ISO 13485 2016Medical Devices Quality Management SystemsAuditor Transition Training Course ISO/IEC 17025Laboratory ISO/IEC 17025 2017Laboratory Management Systems
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
Amcor is a global leader in developing and producing high quality responsible packaging for a variety of food beverage pharmaceutical medical device home and
May 24 2017 13485 2012 MSP US 2 0 Page 1 of 2 Certificate of Registration of Quality Management System to I S EN ISO 13485 2012 The National Standards Authority of Ireland certifies that ICU Medical Inc 951 Calle Amanecer San Clemente CA 92673 USA has been assessed and deemed to comply with the requirements
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
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
Feb 26 2020 Understanding the new requirements and which requirements ISO 13485 2016 fully cover partially cover and do not cover will help medical device manufacturers to comply with MDR Objective This webinar will provide an overview of the similarities and differences between the quality management system requirements of ISO 13485 2016 and of MDR
Apr 07 2021 The ISO 13485 certification for medical devices complements our list of ISO certificates that includes the ISO 9001 for a general quality management system the ISO 17100 that specifies the quality requirements for translation agencies and the ISO 27001 that is the international best practice standard for information and data security
The ISO 13485 standard shares its structure with that of ISO 9001 and includes important factors such as sterile manufacturing traceability and risk assessment This permits the monitoring of the full healthcare product production process from design conception to end destination
Mar 28 2019 ISO 13485 manufacturing is an established quality standard pertaining to medical device manufacturers However as with any quality standard it is more a set of general guidelines which every manufacturer applies to their own situation according to their status infrastructure and working conditions rather than a recipe for success
IAF ISO 13485 Working Group ISO 13485 IAF CONFORMITY ASSESSMENT SYSTEM MAJOR CONTRIBUTIONS TO HEALTHCAREProvides enforceable arrangements to allow participating regulators access to audit reports Provides Medical Device Manufacturers with one ISO 13485 audit that can be accepted everywhere
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
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