Our Journey

Built on experience. Evolved through responsibility.

ELLECOM’s story began in international trade from Frankfurt am Main, where finding the right solution often meant looking beyond borders, building trusted relationships and navigating complex supply chains. Those early years shaped something that remains part of who we are today: the ability to listen, understand a challenge and find a practical way forward.

As our journey continued, we entered the medical device sector and began working closely with manufacturers from different parts of the world. What started with medical device activities gradually developed into a much deeper involvement in regulatory affairs, quality management and international market access.

Working alongside manufacturers gave us an important perspective. Behind every technical file, quality system and regulatory submission is a company that has invested years of knowledge, engineering and commitment into its product and wants to bring that product safely to the people who need it.

Over the years, ELLECOM has therefore evolved into a dedicated regulatory partner for medical device and IVD manufacturers. Today, we support companies in transforming their product knowledge and technical evidence into structured regulatory documentation, implementing and maintaining quality systems, navigating international regulatory requirements, and establishing representation in the European Union and Switzerland.

Our business has changed significantly since the early days, but the principles behind it have remained remarkably consistent: understand the challenge, take responsibility, build trusted relationships and stay committed to the journey.

Because regulatory affairs is not simply about reaching a market. It is about supporting a product throughout its lifecycle and giving manufacturers the clarity and confidence to keep moving forward.

ELLECOM - Connected. Committed to Community.

Meet Our Management Team

Antje Tandetzky

Managing Director ELLECOM SWISS AG

Rohit Zutshi

Managing Director ELLECOM GmbH

  • Our goal is to explore opportunities and resources to improve quality of life through our products and solutions. With a focus on safety and success, we can achieve our mission by working together with others. People are at the centre of our thoughts and actions.

  • Connected and Committed to Community. We aim to provide effective and efficient solutions and products to realize our dream of a united community in which everyone is healthy and has an opportunity to succeed.

  • Quality management is our highest priority. Our Quality Policy is: “Ellecom will always provide products and services that meet or exceed its customers’ requirements. It will always ensure that errors are prevented, deliveries are made on time, and all applicable legal and regulatory requirements are met. It will actively participate in activities that further improve quality and service.”

  • “Ellecom will always provide products and services that meet or exceed its customers’ requirements. It will always ensure that errors are prevented, deliveries are made on time, and all applicable legal and regulatory requirements are met. It will actively participate in activities that further improve quality and service.”

  • We believe that our values are important because they help us grow and develop. As a company, we make hundreds of decisions every day. Our values help us shape the future we want to experience.

    ELLECOM’s values can be summarized as follows:

    Clarity: In our thinking and actions, while keeping our objectives in mind.

    Trust: Openness, transparency and entrepreneurship.

    Loyalty: Acting in the interests of the company and the community as a whole.

    Pride: Being part of a team that works for the benefit of the community.

    Respect: Diversity of opinions and inclusion.