Due to concerns regarding the spread of the Novel Coronavirus (COVID-19), MedtecLIVE GmbH has decided to postpone MedtecLIVE 2020 until 30 June – 02 July. Therefore, Nelson Labs has also postponed our one-day workshop planned in conjunction with the MedtecLIVE 2020 event. The new date for our seminar has yet to be finalized but will be scheduled soon; we will update our website as soon as the date is set.
Following last year’s success, we are ready for the second edition of our ‘one day training on biocompatibility and sterilization’, right at the heart of MedtecLIVE!
Biocompatibility assessments of medical devices are an important part of submission files to regulatory authorities. This one-day seminar looks to understand the new regulations such as the EU MDR and the newly published ISO 10993-18 guideline and the impact they will have on the biocompatibility testing plans of your medical devices.
Learning goals of this one-day workshop include:
- How to apply the content of the ISO 10993 standard when developing a biocompatibility testing plan
- The importance of correct categorization of devices for biocompatibility testing (Level of patient contact)
- Understanding the basic principles of setting up a Chemical Characterization Study following ISO 10993-18 guidelines.
- Learning how ISO 10993-18 and ISO 10993-17 are related
- Exploring different sterilization technologies
- Understanding the processing cycle for reusable medical devices (including cleaning, disinfection and sterilization of reusable devices)
Our industry experts will provide hands-on guidance regarding how to start, with plenty of best practices and interesting cases!
With careful preparation, a successful transition to the new regulatory landscape is possible!
Speakers: Thor Rollins, David Moreels PhD, Emily Mitzel, Stefan Reisbacher PhD (Sterigenics)
COURSE HIGHLIGHTS INCLUDE:
Biocompatibility 10993-1: Case Studies and MDR Impact
10:00 – 11:00
The approach to biocompatibility testing has changed as regulatory agencies from all around the world are expecting a risk-based approach to testing and justifications. This means that “check box” compliance is no longer acceptable. Come hear the biocompatibility strategies that are helping our clients get through the toughest regulations.
Speaker: Thor Rollins
Director Toxicology and E&L Consulting
Chemical Characterization: How this testing will help you meet the new MDR—using our unique Compounds Screener Database to improve testing outcomes
11:00 – 12:00
This presentation describes the basics of a chemical characterization study according to ISO 10993-18, reviewing the three major steps: extraction, detection, and identification. In addition, you will learn how ISO 10993-18 and ISO 10993-17 are related. We will elaborate on the Unique Nelson Labs’ Compounds Screener Database as a key differentiator in obtaining high quality results for chemical characterization studies.
Speaker: Dr. David Moreels
Nelson Labs Europe
Toxicology Assessments: How to identify and lower your risks
12:30 – 13:00
Using chemical characterization to support biocompatibility of medical devices has become a common occurrence. Not only through increased acceptance, but also through heightened requirements Chemical Characterization per ISO 10993-18 of a medical device has become an essential component of overall biocompatibility. This talk will present the framework in which we understand and design these programs, illustrate how they are executed, and close with an overview of how results are used within a toxicological risk assessment per ISO 10993-17.
Speaker: Thor Rollins
Nelson Laboratories, LLC
Introduction to EO Sterilization and Process Validation
13:00 – 14:10
Ethylene Oxide (EO) Sterilization is one of the most important methods for industrial sterilization of medical devices. Learn about the basic principles of EO sterilization and best approaches to successful process validation.
Speaker: Dr. Stefan Reisbacher
EO Packaging Design: Product Definition
14:10 – 14:30
The packaging design is an important aspect of your product definition process for EO sterilization validations. Learn about the special requirements for packaging of medical devices intended for EO sterilization.
Speaker: Dr. Stefan Reisbacher
Processing Validations of Reusable Medical Devices
14:30 – 15:30
Processing validations of reusable medical devices has been a very hot topic for quite some time and the importance of these validations has really taken off recently. The upcoming MDR requirements and heightened US FDA scrutiny regarding reusable medical devices has shed new light on the validation and justification requirements. This presentation will highlight some of the key aspects of what is involved in validation testing for these types of devices. It will give a perspective of what is needed to perform these validations at all stages of the design phase.
Speaker: Emily Mitzel
15:30 – 16:00
We end our program with an interactive Q&A, allowing you to address questions to the day’s presenters or to share any observations and experiences related to Biocompatibility, Chemical Characterization toxicological assessments, and sterility.