Welcome to AstraCon!
We are a family-owned, family-managed and family-friendly consulting company, full of expertise and experience.
Meet the team!
We have scientists, auditors, trainees, managing directors, accountants, mothers, regulatory experts and sisters on board.
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.
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.
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!
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.
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.
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.
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.
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.
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.