Dr.
Carmen Peeß and Malin Baumgarten – Managing Directors
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Malin Baumgarten | Managing director
(Dipl.
economist)
Skills
Projects
Quality Management
Reorganization of the QM system at a Notified Body | development of a new process design and effective change management process | preparation and organization of accreditation audits of the Dutch and Canadian government | implementation of regulatory requirements at the NB and at several Medical Device companies
Subject Matter Expert
Follow-up of corrective actions and effectiveness check | coordination of internal audits | implementation of a global monitoring system for repairable devices in multiple service centers
International Management
Leading an international team working on a global process implementation | hiring of team members | progress monitoring | team lead global complaint handling unit for power tools
Training and coaching
Individual coaching for team leading positions
Dr. Carmen Peeß | Managing director
(German dr. rer. nat.)
Carmen
studied cell and
molecular biology and specialized in immunology and tumour biology. From 2007
until 2015, she worked in R&D diagnostics and pre-clinical drug development
at Roche Diagnostics. She worked with interdisciplinary project teams in the
early product development of anti-tumour drugs, companion diagnostics and
diagnostic products. From 2015 onwards, she actively participated in regulatory
affairs and quality management projects at AstraCon. Carmen joined our team as
a project manager and scientific advisor for the IVD
segment. Carmen
became a managing director of AstraCon in summer 2017.
Skills
MDD (DIRECTIVE 93/42/EEC) and MDR (DIRECTIVE 2017/745)
Implementation and application of regulatory requirements: technical documentation transfer MDR.
EU IVD DIRECTIVE 2017/746
Manager In-vitro diagnostics (TÜV certified): technical documentation, risk management (ISO 14971), performance evaluation | application experience of class A, class B and class C products
Publication and presentation
Preparation of publications and co-inventor of 3 patents | oral/written presentation of scientific data
Laboratory Hands-on experience
projects
MDR and IVDR
Quality Management
Upgrade, GAP analysis of MedTech and IVD companies' QM systems (EN ISO 13485) | development of a new design and development process | implementation
of regulatory requirements at several Medical Device companies
Research and development&D
Pre-clinical
and clinical development of pharmaceutical products | R&D early stage of
companion diagnostics
Dr. FRANZISKA BAUMGARTEN | Senior parnter
(German dr. rer. nat.)
Skills
Strategic consulting for medical devices
Regulatory affairs | quality management | Hands-on solutions | Interim team management | Training and coaching
Communication with authorities
Notified bodies | Competent Authorities | Expert panel
Regulatory aspects of product development
MDD and MDR compliance | Supplier
audits
MDD and mdr
Technical Documentation | Clinical evaluation | Risk management | Biocompatibility
Roles
‘Sicherheitsbeauftragte für Medizinprodukte’
according to §30 German MPG |
person
responsible for regulatory compliance according to the new MDR | ISO 13485
auditor
projects
MedTech start-up companies
Establishing of a
regulatory department | CE mark for the first medical device of a start-up
company
Established enterprises
SOPs for pharma and MedTech
| continuous post market reporting and implementation of related processes
Products
Classification statements for
borderline products | roadmaps for CE | maintenance and establishment of
technical documentations