In the dynamic life science sector, particularly in medical technology, mergers and acquisitions (M&A activities) are becoming increasingly important. In addition to the essential legal and financial reviews, scientific due diligence (regulatory due diligence) plays a decisive role. Our unique approach to scientific due diligence provides a comprehensive and in-depth assessment beyond conventional review procedures. This assessment enables you to evaluate the regulatory value of the company to be acquired.
Why Scientific Due Diligence?
Scientific Due Diligence involves thoroughly analysing the regulatory aspects of a MedTech company or individual medical devices. In the strictly regulated medical technology industry, the focus is on specific key questions:
Regulatory compliance
Do the medical devices in the portfolio meet current and future legal requirements, and are they, therefore, marketable in the short, medium and long term?
Marketability
Is the sustainability of the medical devices and the company guaranteed to meet current and future regulatory requirements in national and international markets?
Technical documentation
Does the technical documentation correspond to the current state of the art? Is it complete and up to date?
Business risks
What potential business risks result from the regulatory compliance audit, and what measures can be taken to minimise these risks?
Our Expertise
Our work complements the conventional due diligence activities of accounting firms and law firms. This minimizes the regulatory and financial risk of transactions and enhances corporate value. Through transparent analyses of investments in regulatory areas and quality management systems, we create significant added value in price negotiations. With our scientific due diligence, we have successfully supported numerous transactions in the MedTech sector, ranging from small acquisitions to large deals. Our clients, including investors (often PE funds) and M&A service providers, value our quick response time and practice-oriented analyses. Our experienced team is ready for international audits on short notice, even under high time pressure.
How can we support you?
Contact us for a non-binding discussion and learn how we can help you make informed and confident decisions.
Bernhard Bichsel
Co-CEO
©
2025
ISS AG, Integrated Scientific Services