UL International Germany GmbH of Neu-Isenburg at MEDICA 2017 in Düsseldorf -- MEDICA Trade Fair
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UL International Germany GmbH

Admiral-Rosendahl-Str. 9, 63263 Neu-Isenburg
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Telephone +49 69 489810-0
Fax +49 69 489810-168
medical.inquiry@ul.com

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MEDICA 2017 hall map (Hall 10): stand G65

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  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies

Technical equipment management, Test houses / Certification Bodies

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.01  Biocompatibility testings

Biocompatibility testings

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.02  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

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Aug 29, 2017

UL Announces GREENGUARD Certification for Medical Devices in Breathing Gas Pathways

MARIETTA, Ga., August 29, 2017 – – UL Environment, a division of UL (Underwriters Laboratories Inc.), a global safety science leader, announced today it has launched GREENGUARD Certification for Medical Devices in Breathing Gas Pathways. This latest standard for GREENGUARD Certification was developed to help manufacturers of medical devices that come in contact with breathing gas pathways demonstrate that their products meet the most rigorous emissions limits. In addition, the testing and exposure assessments that are part of the GREENGUARD Certification process can remove potential market access hurdles and help address regulatory concerns related to the US Food and Drug Administration’s (FDA) 510(k) review process.

“These breathing gas pathway medical devices come into contact with people at a particularly vulnerable point and time. As a result, it’s critical that these devices offer minimal exposure to potentially harmful VOCs. GREENGUARD Certification for Medical Devices empowers manufacturers with data and information that allow them to help ensure the safety of their products for human health and speed the 510(k) review process,” said Alberto Uggetti, vice president and general manager of UL Environment. “We are excited to add this to the line of rigorous GREENGUARD Certification standards that help manufacturers in every industry bring safer products to market.”

UL GREENGUARD Certification for Medical Devices includes testing for VOCs, particulates, and leachables in condensate, as well as a complete risk assessment that models expected exposure during use. The GREENGUARD Certification Mark allows medical device manufacturers to signal to buyers that their products meet strict chemical emissions limits, which support human health, even under these vulnerable circumstances.

This certification is based on the ISO 18562 (Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications) series of standards, which are used for evaluating the biocompatibility of medical devices, parts, and accessories, and increasingly looked to by regulators such the FDA.

For more information about GREENGUARD for Medical Devices, visit ul.com/gg.

About UL Environment

UL Environment works to advance global sustainability, environmental health, and safety by supporting the growth and development of environmentally preferable products, services, and organizations. We help companies achieve their sustainability goals—and help purchasers, specifiers, retailers, governments, and consumers find products they can trust. UL Environment offers environmental claim validations, multi-attribute product certifications, environmental product declarations, indoor air quality certification, product emissions testing, organizational sustainability certification, and consulting. For more information, visit www.ul.com/environment, and connect with us via Twitter, LinkedIn, or Facebook.

About UL

UL fosters safe living and working conditions for people everywhere through the application of science to solve safety, security and sustainability challenges. The UL Mark engenders trust enabling the safe adoption of innovative new products and technologies. Everyone at UL shares a passion to make the world a safer place. We test, inspect, audit, certify, validate, verify, advise and train and we support these efforts with software solutions for safety and sustainability. To learn more about us, visit UL.com

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Aug 22, 2017

U.S. FDA Recognizes UL 2900 for Use in Premarket Reviews

NORTHBROOK, Ill., Aug. 22, 2017 — The U.S. Food and Drug Administration (U.S. FDA) announced today the recognition of UL 2900 as an FDA recognized consensus standard for use in addressing medical device cybersecurity concerns in pre-market review submissions.

“FDA recognition of UL 2900 means that manufacturers now have a standard to provide objective evidence to demonstrate their devices meet FDA expectations for medical device cybersecurity,” said Anura Fernando, principal engineer, Medical Software & Systems Interoperability.

Building on its 2014 pre-market guidance, the U.S. FDA issued additional guidance in December 2016 –  “Post-market Management of Cybersecurity in Medical Devices” – that provided recommendations for managing the security risk of medical devices already on the market. After working closely with regulators and industry stakeholders, UL’s recently recognized UL 2900 standard offers testable cybersecurity criteria to assess software vulnerabilities and weaknesses minimize exploitation, address known malware, review security controls and increase security awareness for network-connectable products in development as well as devices currently on the market.

"While pleased with FDA’s decision to recognize UL 2900, we understand there is a much greater global challenge for manufacturers in navigating global cybersecurity expectations from regulators and health delivery organizations. This uncertainty adds time and cost as manufacturers work to deploy a single design into the global market and are confronted with a growing list of regulatory requirements and purchaser expectations,” added Fernando.. “While still evolving, we will continue to work with stakeholders to drive harmonization and expect cybersecurity to follow a similar path to that of other globally harmonized safety standards, which will help provide certainty to industry as testing is standardized and security concerns are addressed during device design.”

For additional information related to product testing, evaluation or certification questions, email ULCyber@ul.com.

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Aug 14, 2017

UL BECOMES RECOGNIZED AUDITING ORGANIZATION UNDER MEDICAL DEVICE SINGLE AUDIT PROGRAM

Program allows medical device manufacturers to meet quality management system requirements for multiple geographies in one audit.

FREMONT, Calif., Aug. 14, 2017 - UL (Underwriters Laboratories), a global safety science organization, announced today it has successfully completed its assessment and received confirmation by the Regulatory Authorities of the Medical Device Single Audit Program (MDSAP) as a Recognized Auditing Organization (AO). MDSAP is based on the International Medical Device Regulatory Forum’s (IMDRF) program documentation.  Members of MDSAP include the US Food and Drug Administration (FDA),Therapeutic Goods Administration of Australia (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, Japan’s Ministry of Health, Labour and Welfare (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
 
The MDSAP allows a Recognized Auditing Organization to conduct independent MDSAP audits on behalf of the coalition of regulatory authorities including the U.S., Canada, Japan, Brazil and Australia. This single audit approach reduces the need for duplicate quality management audits, helping device manufacturers to better manage costs and ease market access.   

“MDSAP will help streamline the regulatory approvals process and take a lot of the burden off of manufacturers that had to endure audits from multiple regulatory bodies,” said Michael Windler, Regulatory Service Manager, UL Health Sciences division.  “Our team of in-house auditors, who specialize in medical devices and standards have over nine years of experience on average which means it will take them less time to learn the nuances of highly innovative medical products and complex regulations.”

MDSAP is already a strong regulatory driver for manufacturers selling devices in Canada.  After January 1, 2019, it will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program. During the transition, Health Canada will accept certificates issued under both MDSAP and CMDCAS.  UL will be leading a 30-minute live webinar on Wednesday August 16th covering the MDSAP requirements.  Registration is free online at: http://connect.ul.com/Canadas-2019-transition-from-CMDCAS-to-MDSAP-Registration.html

For more information on UL’s regulatory certification services, contact us at Medical.Inquiry@ul.com or visit www.ul.com/medical

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About us

Company details

UL provides the expertise to support medical and IVD companies meet project timelines for global regulatory submissions.   We have a robust team of technical experts throughout Europe and locally in Germany ready to help you with your testing, certification, auditing and CE-marking needs.  

Our services include dedicated auditors who can provide integrated systems registrations for ISO 13485, Canada CMDCAS, MDSAP, ICMED, European Notified Body, Brazil – INMETRO and Risk Management ISO 14971.  Our experienced engineers provide safety assessments and testing for IEC 60601, IEC 61010, CB Scheme and more.  We assess and test all aspects of connected devices safety including wireless, cybersecurity, interoperability and EMC. 

Our Human Factors Engineering (HFE) experts provide usability assessments, training and testing. 

Our pre-clinical experts and GLP laboratories are located in Germany and we have local study directors that provide testing and validation for sterility, shelf life, packaging, biocompatibility, ophthalmic devices and more. 

We are also leaders in air quality testing and can test respiratory equipment and other devices and accessories that come into contact with the breathable air pathways to ISO 18562.  We offer a GREENGUARD Certification to support regulatory submissions and environmental claims.  www.ul.com/environment

Find out more: www.ul.com/medical  

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Company data

Number of employees

> 5000

Foundation

1894

Area of business

Medical Services and Publications

Company information as a PDF file