AstraSwiss joins AstraCon.
AstraCon now serves our customers from Switzerland and the former AstraSwiss customers.
Dr.
Carmen Peeß and Malin Baumgarten – Managing Directors
Dr.
Franziska Baumgarten – Senior Partner
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Malin Baumgarten
(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 EU standards 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
(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 pharma and life science
segment.
Carmen
became a managing director of AstraCon in summer 2017.
Skills
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
Hands-on experience in molecular biology
Isolation, restriction, mutation and ligation of nucleic acids |transformation,
agarose gel electrophoresis, PCR |
sequencing of variable antibody domains
Hands-on experience in protein biochemistry
Recombinant protein expression: eukaryotic and prokaryotic systems | protein purification: affinity chromatography, size exclusion chromatography | protein analysis: 2D epitope mapping, ELISA, immunohistochemistry, surface plasmon resonance, SDS-PAGE, western blotting
Hands-on experience in cell culture
Antibody
development: hybridoma technology | FACS-based cell sorting |
in-vitro cell
culture experiments for the characterization of therapeutic antibodies
projects
Pre-clinical
and clinical development of pharmaceutical products | R&D early stage of
companion diagnostics |
GAP Analysis MDD, MDR
Dr. FRANZISKA BAUMGARTEN
(German dr. rer. nat.)
SENIOR PARTNER
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 management | training and
coaching
Communication with authorities
Notified bodies | competent
authorities | expert panel
Regulatory aspects of product
development
MDD and MDR compliance | supplier
audits
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 9001
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 | due diligence for product acquisitions