Biological Evaluation of Medical Devices and Healthcare Packaging Testing

ISO 11607-1 and ISO 11607-2 recently (2019) have been revised. The presentation is intended to review the key changes and discuss the implications to the validation actions the process of packaging terminally sterilized medical devices:

• legal basis
• key changes from first to second edition of ISO 11607-1
• implications to the validation process
• shelf life study design examples

ISO 10993-1 has been revised in 2018. The biological evaluation process has been changed and the biological endpoints to be considered have also been revised:

• Overview of Biological Evaluation Process
• Upcoming changes to ISO 10993 Parts 3, Part 17 and Part 18

Tuesday 18th February 2020

BIOPILIS

5 avenue du Grand Sablon – 38700 La Tronche

JE M’INSCRIS

Compulsory registration until 14th February 2020 – 1 person/structure

PROGRAMME

From 8h45 : Reception

9h00 – 11h00 : Presentation by Marcus CORZILIUS

Biological evaluation of Medical Devices

• Review evaluation process per ISO 10993-1 to assess biocompatibility of medical devices
• Review recent changes to requirements
• Relevance of chemical characterization
• Q&A

Healthcare packaging testing

• Review recent changes to ISO 11607
• Seal Strength
• Relevance of usability
• Q&A

From 11h00 : individual interviews with the speaker

SPEAKER

About Marcus CORZILIUS

Marcus Corzilius is a Managing Director for the Life & Health Sciences division at Underwriters Laboratories Inc. (UL). With a demonstrated history working in public safety, Marcus oversees medical device product safety testing, process improvement (DMAIC), ISO 17025 adherence and GLP oversight. Marcus is a strong business development professional and is recognized thought leader throughout the global safety science industry.

Marcus previously served as a Health Sciences Engineering Leader, an Engineering Manager, and a Project Engineer, leading UL teams on inter-functional teamwork, performance management, and construction review according to medical and laboratory standards.

Prior to joining UL, Marcus worked for five years as a Chemical Laboratory Assistant at Merck and has been a Design Engineer (Surgical Luminaire) for Heraeus. Marcus has his Dipl.-Ing. (FH) in Biomedical Engineering from the University of Applied Sciences in Giessen-Friedberg, Germany and has completed Yale University’s UL Executive Leadership Program. https://www.linkedin.com/in/marcus-corzilius-363b159/?originalSubdomain=de

PARTICIPATION COSTS

MEDICALPS members: free (1 person/structure)

Non-members fees: 60€ (payment by cheque or bank transfer)

CONTACT

Linda HAOUCINE

Communication manager

linda.haoucine@medicalps.eu

0476549563