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."

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