Regulatory and Quality Due Diligence for M&A in Medtech

We support investors and companies in merger and acquisition projects
with regulatory risk assessments and expert insights.

Gain swift, well-founded decision-making support in a sensitive area.

Understanding regulatory compliance is essential when acquiring or investing in a MedTech company. Whether you are a buyer, investor, or seller, thorough due diligence helps you uncover hidden risks, validate compliance, and plan remediation activities. Decomplix supports you with experienced specialists and proven methodology.

We assess the quality and regulatory conformity of medical device and IVD companies and present you a clear picture of their compliance status.

A pragmatic and structured 4-step approach

Kick-off
- Decomplix starts by understanding your transaction, timeline, and risk appetite to tailor the scope of the due diligence accordingly.
Document Review
- Decomplix reviews core regulatory and quality documentation, including technical documentation, certifications, QMS, labeling, registrations, and vigilance files.
Analysis & Risk Assessment
- Decomplix analyzes the findings and assesses compliance gaps, potential liabilities, and future regulatory costs.
Reporting
- You receive a clear, business-oriented due diligence report highlighting red flags, risks, and recommended actions for your decision-making.

Early due diligence on compliance risks helps buyers and investors make better decisions and negotiate fair terms.

Why Decomplix for your M&A due diligence?

Decomplix provides independent, confidential, and fast results through discreet evaluations and short turnaround times tailored to the pace of M&A transactions.

Decomplix’s team of specialists offers expertise in EU MDR, IVDR, and Swiss regulation (MedDO/IvDO) to identify compliance gaps and regulatory risks.
Decomplix ensures clear documentation and actionable results by translating regulatory complexity into concise reports at a managerial level with practical next steps.

Decomplix’s due diligence services are conducted under an ISO 13485-certified quality management system, guaranteeing structured, consistent, and high-quality outcomes.
Decomplix brings seasoned insight and reliability to every transaction, supporting M&A teams, investors, and corporate development units.

More about us

Contact us

Beni Hirt

Customer Relations & CEO

Beni Hirt has over 15 years of experience in customer relations and project management, particularly in software and business modeling. Beni Hirt builds and maintains partnerships with start-ups, SME, and big entities and supports them to clear regulatory hurdles and shorten the time to market. He is a business administrator and experienced in establishing and running new businesses and models. He also has co-founded and ran one of the most successful Swiss app agencies.

Contact

Email
+41 79 668 02 60

Frequently Asked Questions
about Regulatory Due Diligence

What types of companies benefit from Decomplix due diligence services?

Private equity firms, MedTech investors, M&A advisors, corporate development teams, and manufacturers preparing for acquisition or investment.

How is the regulatory due diligence report structured?

The report includes an executive summary, identified risks, compliance status against key regulatory frameworks, and practical recommendations for risk mitigation. Individual needs can be addressed during the collaboration.

Can Decomplix also help with post-deal remediation?

Yes. We can support with planning and implementing corrective actions after the transaction, including QMS upgrades, labeling changes, and technical documentation remediation.

What is the impact of regulatory non-compliance in M&A transactions?

Regulatory non-compliance can significantly affect deal valuation, timeline, and risk profile. It may lead to unexpected remediation costs, delayed market access, enforcement actions, or even product withdrawal. Identifying such risks early through due diligence helps buyers and investors make informed decisions and negotiate appropriate terms.

Dr. Corina Matzdorf ulrich GmbH & Co. KG, Germany

«Being a German high-quality manufacturer for medical devices with more than 110 years of experience and operating worldwide, we feel very safe with Decomplix.»

Dominik Gutzler CytoSorbents Europe GmbH, Germany

«Decomplix as CH-REP is our partner of choice, providing us with a great comprehensive service and allowing us to focus our internal resources on other projects.»

Claudia Handler CARE diagnostica, Austria

«We appreciate the clear procedure, the professional approach, and the uncomplicated cooperation and highly recommend Decomplix as a business partner.»

Pascal Reichmuth Rikai AG, Switzerland

«Thanks to the comprehensive strategy workshop with Decomplix, we understand how to classify and develop our product Rikai as medical device software.»

Renate Reiss NeoNavia GmbH, Germany

«Due to service quality, regulatory knowledge, and reliability, we can highly recommend Decomplix as CH-REP.»

Nicolas Höfler Groupe Mutuel, Switzerland

«Decomplix gives us the necessary security in the use of software as a medical device during digitalization.»

Markus Piller Medid AG, Switzerland

«The flexibility, broad-based expertise and the will to always find a suitable solution for our problems as a small MedTech company are qualities we greatly appreciate about Decomplix.»

Manuel Baumann Oviva AG, Switzerland

«We benefited tremendously from Decomplix's experience and expertise in working with the Swiss authority, Swissmedic, and with Notified Bodies.»

José Näf nahtlos GmbH, Switzerland

«Decomplix' Regulatory Support helps us quick and uncomplicated — I can thoroughly recommend it to any medical start-up.»

Sang-Il Kim Federal Office of Public Health FOPH, Switzerland

«Decomplix has done an excellent job for the SwissCovid App while working under high pressure. The team is reliable, fast and extremely competent.»

Susanne Vesterinen RFSU AB, Sweden

«It feels very good to have Decomplix as CH-REP.»

Teija Ålander Orkla – Wound Care, Sweden

«We are very satisfied with the support and helpful knowledge of Decomplix as CH-REP.»

Thomas Farner Axon Lab AG, Switzerland

«Thanks to Decomplix' great expertise, pragmatic approach and support, we were ready for the CH requirements for IVD/MD importers and CH-REPs within a short time.»