A family enterprise

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

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
(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