Moving your laboratory-developed test to IVDR compliance with Twist Bioscience and Platomics

Are you ready for IVDR general safety and performance requirements?

Date & Time

May 5th, 2022 | 3pm CEST

Webinar Description

From May 26th, 2022, laboratories and health institutions that offer lab-developed tests (LDTs) in Europe will have to show compliance with the “General Safety and Performance Requirements” as laid out in annex I of the IVDR.

In this webinar you will:
  • Hear how Platomics and Twist Bioscience are partnering to deliver an integrated solution, combining Twist NGS kits with Platomics regulatory services.
  • Learn about the regulatory background on the IVDR requirements and how to tackle them using the Platomics PlatoX® GSPR Assistant.
  • See how your laboratory can generate complete IVDR-compliant documentation for LDTs, starting with a best practice workflow based on Twist products.
  • Find out how Twist and Platomics can help you get your exome and custom assays IVDR compliant.

Webinar Registration

Andreas Oberleitner

Head of Quality Management & Regulatory Affairs

Andreas holds a degree in Biomedical Engineering and has worked in the field of Medical Device Regulation since 2002. As a developer, safety engineer, and project manager for medical device development projects, he gained experience in the technical realization of relevant diagnostic and therapeutic products, specifically in non-invasive cardiovascular diagnostics and neurorehabilitation. As Senior Research Engineer at AIT, Austria’s largest non-university research institution, Andreas was responsible for the implementation and maintenance of the company’s certified quality management system (ISO 13485), as well as the regulatory compliance of AIT’s medical devices. Building on this background, Andreas successfully managed and conducted relevant development and consulting projects for more than 15 years and shared his knowledge in a longstanding role as external lecturer for Regulatory Affairs at UAT Technikum Vienna. Furthermore, he is a member of the Austrian Standards Committee 179 for Medical Technology. Since 2019, Andreas has been Head of Quality Management and Regulatory Affairs at Platomics.

Dr. Michael Wittinger

Head of Business Development & Strategic Partnerships

Michael has a background in genetics, and international research experience in the field of molecular oncology. Since 2011, he has worked in the diagnostic industry at the edge of genomics and digital medicine. He has supported the establishment of several startups in the European market and, in 2021, took the role as Head of Business Development at Platomics.

Dr. Sebastian Grömminger

Strategic Consultant for In Vitro Diagnostic Medical Devices
Johner Institut GmbH

Sebastian is molecular biologist and expert in the field of molecular genetic in vitro diagnostics. At Johner Institute, he supports clients in the certification, development, and maintenance of QM systems according to EN ISO 13485, as well as in the implementation of the standards EN 62304 and EN ISO 14971, and the approval of in vitro diagnostics. Following his doctorate in the field of virus-associated tumor development at the Helmholtz Centre in Munich, he played a decisive role in the development, practical implementation, approval, and performance evaluation of non-invasive prenatal examination methods. With his experience in development and diagnostic routine, he has taken over Quality Management and Regulatory Affairs.

Shakil Ahmed

Senior Director of Regulatory Affairs and Quality Assurance
Twist Bioscience

Before joining Twist in 2018, Shakil held quality, regulatory compliance, and process excellence roles in life sciences, medical devices, and pharmaceutical industries. He has spearheaded various quality and regulatory strategies for small and large organizations. He has also established quality management systems (QMS) to support various global international regulatory requirements.

Shakil earned a B.S. in Industrial Systems Engineering at San Jose State University, California, and a M.S. in Engineering Management and Leadership at Santa Clara University, California.
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