Dr.
Carmen Peeß and Malin Baumgarten – Managing Directors
An international network
You can rely on our partnerships with highly skilled specialists.
"Be like the stem cell –
Differentiate yourself
from others."
Unkown
Malin Baumgarten | Managing director
(Dipl.
economist)
Malin is active in the field of
certification for medical devices and process optimization since 2007. As
quality manager for one of the leading notified bodies in the EU she was engaged
in the improvement of the QM system. Since 2013 she has built QM systems (QSR and ISO 13485) for clients of
AstraCon for various product types, leaded implementation processes for new
regulations and a global reporting system and worked on technical
documentations. Malin is founding member and managing director at AstraCon.
Skills
Post market surveillance | complaint
handling | process development and continuous improvement | product
investigations | CAPA determination, implementation of corrections, corrective and
preventive actions, follow-up and effectiveness-check |FDA medical device reporting and determination | EU
vigilance | In-depth knowledge of EUstandards and FDA QSR
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
Standard molecular biology methods | Standard protein biochemistry | Recombinant protein expression | Immunohistochemistry | ELISA |
Surface plasmon resonance | Cell culture methods | Hybridoma technology | FACS-based cell sortin | In-vitro cell culture experiments
for characterization of therapeutic antibodies
projects
MDR and IVDR
Design and implementation of individual roadmaps to IVDR or MDR transition | OEM-PLM strategic consultancy | GAP analysis and update of Technical documentations | QMS update regarding the new regulations
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.)
Franziska graduated in microbiology and
worked for pharmaceutical clinical research at Smith-Kline Dauelsberg and for
sales and business development at AstraZeneca and Novartis. She worked for four
European notified bodies for medical devices (KEMA, DEKRA, Eurocat, BSI).
Franziska is our first contact in Switzerland and Senior Partner of AstraCon.
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