Statement Professional Experience with Devices PMS
I have been working as a regulatory consultant for 10 years. Three of my recent project were PMS projects including procedures/process development and training (Thermo Fischer Scientific, Sfm, Noras). This also included the implementation of PMS-plans for different product lines.
I am also co-author of „Praxis Medizinprodukterecht“, TÜV Rheinland media. In this guide to the implementation of national and international regulations I commented on MDR articles 83 (Post Market Surveillance System of the Manufacturer) and 84 (Post Market Surveillance Plan).
I also contributed as an author of the following RAPS materials, that included guidance on PMS:
- Medical Devices: EU Regulations“ (2020)
- „RAC Medical Device Toolbox” (2018)
- “Intro to Regulatory Affairs in EU” (2016)
As the Co-founder of the Germany RAPS-Chapter and Board member I co-organized and moderated two Chapter meetings on PMS.
Curriculum
Name Leukers, Barbara
Address Helenenstraße 53, 53225 Bonn
Phone 0160 / 21 49 235
E-mail-address info@leukers-consulting.com
Education: Dipl. Chem. (FH), University of Applied Sciences, Rheinbach, Germany
Certifications:
- RAC Regulatory Affairs Certified, US Scope, RAPS (Regulatory Affairs Professionals Society), 2012
Certificates:
- Certificate in Regulatory Affairs (Medical Devices), RAPS (Regulatory Affairs Professionals Society), 2011
- Certificate in Regulatory Affairs (Pharmaceuticals, Biologics and Devices), University San Diego, 2011
- Certificate Manager Regulatory Affairs, TÜV–Süd Akademie, 2010
- Certificate Project Management, TÜV–Nord Akademie, 2007
Languages:
- German (mother language), English (fluent), Spanish (basics)
Consulting Projects (since 2012)
Stryker Leibinger GmbH & Co KG (since May 2021, class I – III non-active devices)
- Integration project Wright Medical Group N.V.
Thermo Fischer Scientific GmbH (4 month, in-vitro diagnostics)
Paul Hartmann AG (17 months, class I – III non active devices)
- Project support MDR Implementation
Sfm (<1 month, class I – IIa non active medical devices)
Abiomed Europe GmbH, (3 months, class III active implantable medical devices)
Noras GmbH, (10 months, class IIa, active medical devices)
- Project Lead MDR Implementation incl. PMS
Sanofi AG, (7 months, medicinal products)
Fresenius Medical Care GmbH (17 months, class IIb active devices)
- FDA readiness project (including MDSAP requirements)
KBL AG (2 months, class II (US), active devices)
- FDA inspection preparation
Siemens Healthcare GmbH (9 months, class IIa/IIb/III active devices)
- Sub-project lead complaint process
Unity Lab Services Part (Thermo Fischer Scientific) (1 month, contract organization for Pharma)
Resorba GmbH (Advanced Medical Solutions) (6 months, class III non active devices)
- Project lead validation CFR 820 and ISO 13485
Boehringer Ingelheim microParts GmbH (11 months, class III combination products)
- Restructuring complaint and CAPA process to comply with 21 CFR 820 as part of FDA remediation project / Interim management complaint management
Berchtold GmbH & Co. KG (Stryker) (6 months, class I active devices)
- Project lead upgrade QM-system acc. FDA-requirements / Interim management QA
Voelker GmbH & Co. KG (Hill-Rom) Witten (3 months, class I active devices)
- Project lead FDA inspection preparation
Notified Body SGS Germany GmbH (2012–2018)
Professional Education
Lohmann und Rauscher GmbH & Co. KG, Neuwied (class I-III non active devices)
01/2008 – 12/2011 Head of Quality Assurance and Quality Control
Center of Advanced European Studies and Research (CAESAR), associated with Max-Planck-Gesellschaft, Bonn
01/2007 – 12/2007 Project lead dental bone grafts
12/2002 – 12/2006 Research Associate
Academic Studies
University of California San Diego UCSD Extension
03/2011 – 12/2011 Regulatory Affairs: Certificate Regulatory Affairs
University of Applied Sciences Bonn/Rhein-Sieg
09/1998 – 08/2002 Diploma in Chemistry (FH)