Identify regulatory risks before they become a problem.
Regulatory Due Diligence
In investments, acquisitions, or strategic partnerships, the regulatory environment significantly influences risks, timelines, and costs. Incomplete documentation, unclear regulatory status and strategy, or weak QM structures can have substantial consequences if identified too late. We provide investors, management, and transaction stakeholders with a sound basis for decision-making.
How robust are the product, documentation, Quality Management System, and Regulatory Strategy really?
In M&A processes, investments, or partnerships, this is the critical question. Not whether everything is formally in place – but whether it holds up. We provide independent, realistic, and transparent evaluations – transparency instead of assumptions, risks instead of wishful thinking.
Our services in the area of Regulatory Due Diligence
Assessment & Analysis
- You know how robust the product, Technical Documentation, and clinical evidence really are
- Approval status and regulatory strategies are realistically evaluated – nationally and internationally
- The QM System is evaluated and classified according to applicable regulations (ISO 13485, MDSAP, MDR/IVDR, and other national regulations), as well as efficiency and maintenance effort
GAP- & risk evaluation
- Regulatory gaps in the Quality Management System, Technical Documentation, and approvals are identified and prioritized
- Time, cost, and approval risks are realistically evaluated – no surprises after the transaction
- “Red Flags” are identified
- You receive a clear Risk Map as a basis for negotiations and decisions
- Identified QMS gaps must be closed – in a structured, efficient, and audit-ready manner.
→ QM & Audit Support
International perspective
- National and international market access strategies are evaluated and reviewed for viability
- The transferability of existing documentation to international markets is analyzed
You’re facing a decision – we provide the basis for it.
Please get in touch with us to discuss your specific due diligence requirements.
Discuss due diligence requirementsWhen companies and investors come to us
M&A & investments
Regulatory risks of a target company must be evaluated before the transaction.
Strategic partnerships
The regulatory viability of a partner or product portfolio must be evaluated.
Product change
Existing documentation must be updated
Our services
Our customers
Medical Device
manufacturers
Start-ups
Suppliers for medical devices / IVD
Authorities
IVD manufacturers
Investors
Frequently Asked Questions about Regulatory Due Diligence
Regulatory Due Diligence is the structured evaluation of the regulatory situation of a company or product portfolio – in the context of investments, acquisitions, or strategic partnerships. It examines whether approvals, documentation, Quality Management System, and Regulatory Strategies are viable – and what risks, costs, and time commitments arise if they are not. In the medical device industry, it is particularly critical because regulatory deficiencies can directly jeopardize the marketability of products.
The most common risks: incomplete Technical Documentation not compliant with MDR or IVDR, weak or inefficient Quality Management Systems, unclear classifications, and missing or outdated international approvals. Additionally, there are risks from open nonconformities with notified bodies or authorities. We identify these risks in a structured manner – before they influence the purchase price, contract structure, or post-merger integration.
This depends on the transaction structure. In a share deal, certificates and approvals generally transfer to the buyer – provided the underlying QM structures and documentation remain intact. In an asset deal, it is more complex: approvals are administrative rights that are not automatically transferred. Which certificates are affected, how long they remain valid, and what needs to be considered during the transition – we clarify all of this within Regulatory Due Diligence.
As early as possible in the transaction process – ideally in parallel with the Financial and Legal Due Diligence. Regulatory risks can significantly influence the purchase price, trigger warranty claims, or, in the worst-case scenario, be a deal breaker. Anyone who discovers regulatory risks only after the contract is signed bear the consequences alone. We deliver reliable evaluations even under time pressure – aligned with the transaction process.
This is difficult to answer in general terms – but experience shows: regulatory remediation after a transaction is almost always more expensive than thorough Due Diligence beforehand. Missing MDR or IVDR compliance, weak Quality Management Systems, or invalid approvals can lead to delays in market launches, recalls, or regulatory sanctions – with significant financial and reputational consequences. Early clarity is the most cost-effective investment.
Whether it’s a transaction, investment, or strategic evaluation – we support you in evaluating regulatory risks early and reliably.