ABOUT US

AstraCon - A Family Enterprise

Company

Welcome to AstraCon!
We are a family-owned, family-managed and family-friendly consulting company, full of expertise and experience.

Team

Meet the team! We have scientists, auditors, trainees, managing directors, accountants, mothers, regulatory experts and sisters on board.

Partners

We happily rely on our network of partners and friends. They are ready to support and help us, should your requirements call for unique expertise or resources.

ASTRACON - A FAMILY ENTEPRISE

We are a family-owned company and are specialized in strategic regulatory consulting for medical device and IVD companies, situated in Germany. Our task is to help you with your work and questions around Regulatory Affairs and Quality Management.

Our customers are manufacturers, importers, EC representatives, suppliers, and distributors from all over the world. Generally, we show them how to use seemingly complicated and oppressive regulations to their advantage. To achieve this, we provide individual and practice-oriented assistance. If desired, we also lend a hand ourselves. Whether technical documentation, QMS implementation (ISO 13485) or strategic consulting for the regulatory future of your company:

We take care of your company and your devices with expert knowledge and passion.

Our Philosophy

Many stakeholders perceive regulations as a burden and an obstacle on the road to CE and market access. Escpecially start-ups and SME. But we can transform them into powerful tools, if we apply them in a smart and practical way. With this in mind, we use these tools to turn your regulatory burden into a driver for your success. Let us show you how it is done!

Our Approach

We are convinced that any failure in a company’s quality management system can lead to patient harm. Therefore, safety and risk-based approaches are the basis of our daily work. With that in mind, we show you how to apply them to the processes of your company, and also to every aspect of your medical device. Above all, this approach enables us to make the medical world for patients safer – step by step.

ASTRACON - THE TEAM

The AstraCon team forms a close-knit community, both professionally and personally. We have known one another all our lives and know the exact strengths and weaknesses of each of us. We trust each other blindly and are masters of communication. Our clients benefit greatly from this well-coordinated team. We ensure short communication channels and achieve a high level of regulatory harmony, professional expertise and enthusiasm for our work. In short:

At AstraCon there is much laughter and many productive discussions

Malin Baumgarten

Creative Entrepreneur. Always on the lookout for the unknown, Malin creatively opens doors that others didn’t even know were there. Questioning old thought patterns and rethinking every detail are just an example of Malin’s many wonderful qualities. With a keen sense for cultures and intercultural peculiarities, she is a master at questioning conventions and embracing diversity. In this way, she contributes greatly to the fact that we as a family and company not only follow in traditional footsteps, but also leave our own.

Dr. Carmen Peeß

Energetic problem solver. Carmen is our sinus node, our impulse, the one who sets the rhythm of AstraCon. The secret of where she gets all her energy besides being a loving mum of three very young children must be that she invented an inner Perpetuum mobile. When others are still asking for the „if”, Carmen is already working on the „how“. Carmen is always thinking in solutions and counts on the real participation and appreciation of everyone who works with her. Every day she manages to balance her professional competence and business intelligence. She uses these qualities to find solutions for the regulatory challenges of our customers.

Dr. Franziska Baumgarten

Strategic Visionary. Franziska, with her many years of expertise in the medical device sector, loves to support clients when they are faced with tricky business decisions and complex strategic planning. With a lot of finesse and an eye for innovative ideas, she helps our clients understand that regulations can indeed be used as a powerful tool and how to leverage them for successful business development. Always looking for new ideas for us and our clients, she is a creative engine for our (corporate) family.

Silke Baumgarten

Curious Inventor. With her intuitive understanding of presenting complex issues in a simple way, Silke inspires clients and colleagues alike. Her love of scientific puzzles and puzzling sciences certainly helps. The glint in her eyes is always a good indicator of how exciting the problem she is currently tinkering with is. It also serves as a warning for us not to disturb her at that moments. Her green fingers not only make plants sprout, but also our company culture thrive. With her strong moral compass, she strengthens our belief that even small businesses can do great things for the environment and our planet.

Susanne Steinau

Progressive Implementer. With a keen eye for the smallest imperfections in workflows and accounting issues, Susanne makes sure everything runs like a well-oiled machine. She lives by the principle that every process can always be optimised and seeks practical and applicable solutions. True to the motto: standstill is regression, the heart of a true quality manager beats within her. Her open and cheerful manner, coupled with an honest interest in her fellow human beings, ensures that we always have a place to turn to for all our worries and concerns.

Our partners

mdi Europa GmbH was founded in March 2000 to provide medical device manufacturers world-wide with flexible and well-adjusted service packages to assist clients to comply with EU legislation. The company acts as European Authorized Representative (as defined in the Medical Devices Regulation (EU) 2017/745 (MDR), the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the Medical Devices Directive 93/42/EEC (MDD) and the In Vitro-Diagnostic Medical Devices Directive 98/79/EC (IVDD)) for a wide range of companies – from start-ups to established corporations throughout the world.

ELAVITY is a unique venture consulting & venture building firm representing creative clients in and between Europe, UK and USA. They specialize in providing consulting services with a strong focus on finance, fundraising, valuation and exit strategies. They also provide consulting on market and go-to-market strategies with a special focus in medtech, biotech, digital health and software. They guide new ventures in variety of modules throughout the commercialization of technology and join forces with Technology Transfer Offices and Academia as well as corporates. They are proud to work with partner firms who bring in their expertise in Intellectual property, Legal, Regulatory and Software Development.

With extensive knowledge of the life sciences and the US market, BioPortUSA addresses your unique needs and provides a customized plan and suite of services administered in one place, making the entire process seamless and pain free. BioPortUSA saves you time and provides unprecedented access to industry leaders in their respective fields including: Market Research, Legal, IP, Regulatory, Reimbursement, and Sales & Marketing. Their understanding of this highly regulated and complex healthcare industry enables our clients to accelerate the path to commercialization within a framework that maximizes cost efficiencies.

OUR FRIENDS

Windcloud is the sustainable data centre operator and provider of cloud and colocation solutions from the far north of Germany. Their special feature: they supply their data centre 100% with physically genuine green electricity, largely from wind energy. In addition, they have developed a concept for the re-use of the waste heat generated.
They have built an algae farm on the roof of their data centre, which they heat with the waste heat from the servers. This allows them not only to operate their data centre CO2-free, but also to absorb additional CO2 from the environment.