A family enterprise

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."


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.


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


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.


MDD (DIRECTIVE 93/42/EEC) and MDR (DIRECTIVE 2017/745)

Implementation and application of regulatory requirements: technical documentation transfer MDR.


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



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

(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.


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


‘Sicherheitsbeauftragte für Medizinprodukte’ according to §30 German MPG |
person responsible for regulatory compliance according to the new MDR | ISO 13485 auditor


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  


Classification statements for borderline products | roadmaps for CE | maintenance and establishment of technical documentations