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ISO ISO 13485 ISO 14971 ISO 5356 1 ISO Europe CE marked as Class IIa device in accordance with Council Directive 93/42/EEC Medical Device Directive as amended by Council Directive 2007/47/EC USA Cleared under 510 k as a class 2 device Canada Holds a class 2 medical
How to register You will need to register your medical device through the Medical Device Information Communication System MEDICS You will need the following in order to access MEDICS If you encounter technical issues e mail the HSA helpdesk or call 6776 0168 from 7 00 am to midnight daily
NSAI ISO 13485 2016 for Mar Cor Purification U S ISO Certificate Medical Water Commercial Industrial Services ISO Certification View medical water commercial industrial services iso certification
medical device packaging materials and systems conform with the requirements of the ISO 11607 series of standards Packaging for terminally sterilized medical devices And in the U S the FDA accepts evidence of compliance with ISO 11607 in support of 510 k applications for the approval and registration of medical devices
International Student Insurance is the premier destination online for international student health insurance and international student travel insurance plans Our plans are not only comprehensive but they are affordable for any budget and are specially designed to provide health insurance for
HELIOS High Throughput Aseptic Isolator for Vials and Syringes Filling HELIOS is a fully automatic system able to provide an aseptic GMP dispensing process on vials and syringes It is possible to have in the same batch different vial format different syringe format or even a hybrid batch of vials and syringes
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
Our physicians verify medical content and extract knowledge from medical science literature and published medical cases With over 1 360 symptoms 740 conditions and thousands of supplementary medical concepts for children and adults Infermedica can claim to have one of the most comprehensive medical databases in the world
Try isoTracker free for 60 days Thank you for your interest in a 60 day free trial During the free trial period you will get the following benefits Assurance that you can keep all your data when you decide to subscribe to isoTracker Please provide the information below and we will immediately create your personalized demonstration account
Rhinoswab is a safe alternative to standard of care swabs 1 There have been no adverse outcomes associated with Rhinoswab to date other than occasional light nasal spotting when the swab is removed 1 There are no specific contraindications for collecting samples with Rhinoswab
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
Our Small Volume Parenteral Stoppers Serum Stoppers are designed for blowback and non blowback vials and provide optimal protection and drug delivery Our range of pharmaceutical rubber Serum Stoppers are designed to meet multiple piercing needs and facilitate manufacturing processes
ISO13485 The Importance of Management Review ISO 13485 is a regulatory standard whose focus is meeting customer requirements including regulatory requirements and maintaining the effectiveness of the Quality Management System QMS Section 5 of the standard requires management involvement and responsibility for the effectiveness of the QMS
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
Learn more about devices such as diagnostic tests ventilators and personal protective equipment PPE including surgical masks face shields respirators gowns and gloves Jun 30
Predictable Retains spherical shape with consistent cross sectional diameter after reconstitution with aqueous based solutions such as contrast media and 0 9 saline solution for predictable flow directed level of occlusion in the vasculature Conformable Affords atraumatic conformability to the architecture of the vessel lumen providing more contact surface area with the embolic
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
ARGO 2 0 Vial Dispensing System Used in GMP Radiopharmacy Radiopharma For Filling Dispensing Dose Calibration ARGO is an automatic dispensing system for vials The equipment is designed and produced to dispense radiotracers used in PET and SPECT diagnosis and therapeutic radiopharmaceuticals ARGO is a system that complies with the cGMP
Certify your quality management system for medical devices with ISO 13485 Perhaps more than any other type of manufactured product the quality of medical devices has a direct impact on their effectiveness as well as the safety of patients users and where appropriate other persons
BD Corporate contact information BD Headquarters Address Becton Dickinson and Company 1 Becton Drive Franklin Lakes NJ Corporate phone number 201 847 6800 Investor information
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
The ISO 9000 family is the world s best known quality management standard for companies and organizations of any size ISO 14000 family Environmental management Improve your environmental performance with this family of standards
A challenging transition period While the new European Union Medical Devices Regulation MDR will not become effective until May 2021 after the recent postponement by one year some immediate actions are required of medical device manufacturers We are currently in the transition period but pressure is rising with demands for stricter
Please select a webinar group you are interested in The Medical Device Single Audit Program MDSAP The Medical Devices Regulation MDR Market access requirements QMS ISO 13485 and medical devices standards The In Vitro Diagnostic Regulation IVDR Please select which services you re interested in and one of our team will be in touch CE
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
Gastroesophageal reflux disease GERD is a condition in which the stomach contents leak backwards from the stomach into the esophagus the tube from the mouth to the stomach This can irritate the esophagus and cause heartburn and other symptoms Nowadays GERD is a common condition and its prevalence varies in different parts of the world
Electronic systems in medical equipment devices and probes rely on sensor signals as a basis for control activities accurate diagnosis and treatment TE designs and manufactures sensors to exacting specifications for the rigors of medical applications with ISO 13485 certification and FDA registration for various products
As Senior Director of Quality and Compliance at Yukon Medical she oversees the activities to maintain and enhance Quality Management System compliance with 21CFR Part 820 ISO 13485 and multiple ever changing international regulations for vial access and IV administration medical devices
ARGO T TRANSSEPTAL is an automatic dispensing system for closed vials able to fill a vial through rubber stopper The equipment is designed to dispense radiotracers used in PET and SPECT diagnosis and metabolic radiotherapy ARGO T is a system that complies with the cGMP guidelines for filling closed vials Information request
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
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
Qualifications ISO 9001 ISO 13485 FDA Registered Supplier to Medical Manufacturers Markets Supplied Worldwide Flexan is a global manufacturer that delivers cleanroom manufactured assembled and packaged molded components silicone and thermoplastic for use in implantable Class III devices and disposable Class II and Class I medical devices
FDA or ISO 13485 is expected to remain the most dominant certification of the market over the next five years Regional Insights North America is projected to remain the dominant market for life science/medical processing seals over the next five years whereas Asia Pacific is likely to provide the highest growth opportunity during the same period
Baby Phill small batch vial filling system the Comecer approach to the production of small batches for R D Pharmaceutical or ATMP 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 Health and Safety
03 July 2018The German and French quality management systems of seca the leading manufacturer of medical measuring systems and scales have been certified according to the revised standards ISO 9001 and ISO 13485 in an audit conducted by TÜV Süd In addition the quality management system at seca headquarters in Hamburg received the Medical Device Single Audit
To lift or lower the vial within the container or the Intego Infusion System a detachable handle is provided Accommodation is made for the handle to travel with the shipping container The system meets DOT Yellow II Type A packaging requirements when shipping up to 2 5 Ci 92 5 GBq of FDG F 18
