UL International Germany GmbH of Neu-Isenburg at MEDICA 2017 in Düsseldorf -- MEDICA - World Forum for Medicine

UL International Germany GmbH

Admiral-Rosendahl-Str. 9, 63263 Neu-Isenburg
Telephone +49 69 489810-0
Fax +49 69 489810-168

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MEDICA 2017 hall map (Hall 10): stand G65

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MEDICA 2017 fairground map: Hall 10

Our range of products

Product categories

  • 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

Company news




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


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



Area of business

Medical Services and Publications

Company information as a PDF file