We know what makes a successful medical device
For more than 20 years, Schrack & Partner has been supporting medical device manufacturers and research facilities with professional services and training courses relating to the design, development, manufacture and authorisation of medical devices. However, our expertise also extends to related topics, such as occupational safety and safety-related supervision, for which we can also provide qualified support.
Our interdisciplinary team of scientists and engineers always keep their eyes on the big picture for you. The members of our team include lead auditors and occupational safety specialists. We derive our strength from our years of practical experience in our specialised field. An additional benefit is our outstanding external network of experts and specialists, who we can call on to work on your projects.
Our customers come from the medical device industry, pharmaceutical industry, and life sciences research facilities. As a small yet effective team, we support research facilities and small, medium-sized and large businesses.
Schrack & Partner currently works with about 350 companies around the world. Since confidentiality is our top priority, we enter into binding confidentiality agreements with our customers; as a result, we hope you will understand that we cannot provide a list of case studies or references here. If you have any questions about previous projects we have worked on, or require a reference, please contact us and we will work with you to find a solution.
Did you know?
Businesses around the world rely on Schrack & Partner's qualified services.
Passion and expertise since 1998
Michael Schrack's business is founded on 1st January 1998 as the engineering firm Schrack Unternehmensinnovation.
Until then, Michael Schrack was head of the European notified body DEKRA Certification Services GmbH, which is now called DEKRA Certification GmbH. The underlying principle of the business has always been extensive, comprehensive expertise in the field of medical devices from its very beginnings.
On 22nd December 2004, the engineering firm becomes the registered partnership "Schrack Unternehmensinnovation, Schrack & Partner". Three partners have led the business together since 2004: Michael Schrack, Roland Hartmann and Dr Sibylle Heinrich.
Over the next few years, the team gradually expands with the addition of new assistants and consultants. An extensive network of partners is also established.
Schrack & Partner's move to the Technologiepark Tübingen-Reutlingen (TTR) provides an ideal new infrastructure – excellent transport links give rise to benefits for the company and its customers. The company's new premises at the TTR enable the team to plan training programmes and events on a much larger scale, equipping it for whatever the future brings!
Christoph Kiesselbach joins the team, bringing new expertise to the table. Having previously worked as a project and study director in the field of pre-clinical evaluation of medicinal products, his prior expertise in medicinal product testing and authorisation enhances Schrack & Partner's expertise in device verification and validation.
The first evening event held for Schrack & Partner's customers represents the start of a new era of events: Together with novineon CRO GmbH and the law firm Voelker & Partner, Schrack & Partner invites its customers to an enjoyable, informative event. The "Mini-symposium on medical devices" series of events is born!
Markus Dorsch moves from a role in industry to Schrack & Partner, adding his extensive experience to the team. Until mid-2015, Markus was in charge of quality management and regulatory affairs at a medium-sized international business in the medical technology sector.
In 2016, the management team is reorganised: As of 1st January, Michael Schrack, Dr Sibylle Heinrich, Christoph Kiesselbach and Markus Dorsch are the managing partners.
Schrack & Partner celebrates its 20th birthday!
The pandemic changes how the world thinks about project-based work; the Schrack & Partner team and its customers continue their work from home offices and in online meetings. Fortunately, the company is able to continue working successfully on its projects despite restrictions. Turning this difficult situation into an opportunity for growth, Schrack & Partner soon reaps the benefits of virtually organised meetings. Online training courses and the company's first online mini-symposium are organised and held virtually to great success, becoming almost routine by the second half of the year.
In 2021, after a long period of preparation, an important date for the company and its customers finally arrives: Regulation (EU) 2017/745 comes into force on 26th May 2021. Its implementation by manufacturers and institutions remains an exciting process and is sure to involve many new experiences over the year.
At Schrack & Partner, the team watches the course of the pandemic, looking forward to being able to meet the company's customers face-to-face again soon.
Careers at Schrack & Partner
We are continuously expanding our range of services. To do this, we always need new, highly qualified team members – could this be you? Have you completed a degree in natural sciences, engineering or medicine? Do you already have practical experience in medical device design and development, medical device manufacturing, or product management? Could you see yourself working as part of a team of consultants?
If your answer to these questions is yes, we look forward to receiving your application!
Please send your application documents by e-mail to:
Dr. Sibylle Heinrich