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Partner Event: UL Non-Clinical Testing Roadshow
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Partner Event: UL Non-Clinical Testing Roadshow

To help keep you and your company updated on the global regulations and requirements for non-clinical testing, UL is planning a series of seminars led by one of the leading experts in non-clinical studies. The speaker, Mr. Jan Peeters, Global Program Manager, Scientific Director & Primary Designated Engineer (PDE) will be traveling from Germany to present a series of five seminars in the US, including an exciting event in St. Petersburg, FL on February 5, 2015.

2/5/2015
When: 2/5/2015
10:00 AM
Where: Nypro, A Jabil Company
10560 Dr. Martin Luther King Jr. Street North
GSB Building
St. Petersburg, Florida  33716
United States
Presenter: Mr. Jan Peeters, Global Program Manager, Scientific Director & Primary Designated Engineer (PDE)
Contact: UL
1.888.503.5537

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As a medical industry professional, it is critical to be informed about topics that affect global regulatory approvals.  To help keep you and your company updated on the global regulations and requirements for non-clinical testing, UL is planning a series of seminars led by one of the leading experts in non-clinical studies.    UL offers the health sciences industries a way to complete another requirement of the complicated regulatory submissions process through one provider. UL’s non-clinical test services meet the requirements of the specifications generally accepted by the major global medical device markets. Working with UL for non-clinical testing provides the benefit of test plan consolidation, which can be faster than managing multiple test labs.  Biocompatibility is defined as “compatibility with living tissue or a living system by not being toxic, injurious, or physiologically reactive and not causing immunological rejection.” For medical devices, which come into contact with the human body for the purpose of treatment, diagnosis, or physical aid, making sure that every point of contact will not cause irritation, changes in blood composition, or toxic response is especially critical. Even if a material that makes up the medical device has been tested for biocompatibility, processes such as manufacturing, packaging, aging, and sterilization may have adverse effects on the material’s composition and how it reacts in different environments. Because of these potential changes, biocompatibility is an important test protocol that must be completed for every medical device end product prior to receiving global regulatory approvals.

We are going to be presenting an exciting event in St. Petersburg, FL on February 5, 2015 from 10:00 am – 2:30 pm.  During this time, we will provide information on:

·        Material Characterization for more focused testing and cost savings

·        Validation needs for packages of medical devices – Packaging processes, shelf-life and transportation

·        ISO 10993 Series of Standards – Regulatory updates and requirements

The speaker, Mr. Jan Peeters, Global Program Manager, Scientific Director & Primary Designated Engineer (PDE) will be traveling from Germany to present a series of five seminars in the US.  Mr. Peeters has over 35 years of experience in Analytical Chemistry and Chemical Engineering and currently serves as UL MDT’s Global Program Manager and Scientific Director & Primary Designated Engineer.  He has been managing and directing the laboratory operations and studies for medical devices since 1995.  Mr. Peeters’ expertise includes analysis of chemical substances in medical devices and related toxicological issues, ophthalmic and dental medical devices and their testing procedures and packaging validation and stability testing.  He actively participates in many medical device standards committees and national working groups including German NA 027-01-20 AA: "Intraocular Medical Devices", German NA 063-04-04 AA: "Sterilgutversorgung” (sterility supply) and ZLG Horizontal Working Committee “Cleaning, Disinfection, Sterilization.”  He works out of the UL MDT facility in Ochsenhausen Germany and supports the global UL team.

The Registration URL is: http://web.ullifeandhealth.com/Non-Clinical_Roadshow

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