Regulatory due diligence for medical devices – investment security in two weeks
In transactions in the MedTech sector, the regulatory status of your medical devices and IVDs is a key factor in determining value, risk and time-to-market. With our structured regulatory due diligence, we provide you with a fact-based basis for decision-making before you invest.
What is regulatory due diligence?
Regulatory due diligence is the systematic review of the regulatory status and compliance risks of medical devices and in-vitro diagnostics as part of investment decisions. It supplements financial, legal and commercial due diligence with the perspective of MDR, IVDR, ISO 13485, FDA requirements and other relevant regulations.
While a financial due diligence analyzes balance sheets and a legal due diligence examines contracts, we evaluate technical documentation, conformity assessment procedures and post-market surveillance processes. The aim is to create transparency regarding conformity, approvability, documentation quality and future costs for maintaining or establishing compliance. This is because an appropriate purchase price for medical devices can only be determined if the marketability and potential compliance risks in the further product life cycle are clearly evident.
Regulatory due diligence is precision work – and time pressure is part of it. We provide you with a well-founded assessment within two weeks, which you can incorporate directly into your transaction decision. No vague assessments, but clear facts: on compliance status, risks and the realistic costs for the future
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Ensuring a faster market launch
Avoid costly delays through early detection and resolution of regulatory hurdles. We identify expiring certificates, missing clinical data or QMS gaps before they become a problem. Our assessment is available after just two weeks and gives you planning security for the time after the transaction.
Securing global marketing
Ensure that you can sell your medical devices and IVDs in all target markets. We check the requirements of all relevant markets, from EU MDR and IVDR to FDA and other international regulations, in one go. You do not have to coordinate several specialists for different markets, but receive an integrated assessment from a single source.
Minimize investment risks
Make your purchase decision based on transparent facts instead of vague estimates. Our traffic light assessment shows you precisely where you stand in regulatory terms and what costs you will incur. You receive realistic time and cost estimates for necessary compliance measures and can incorporate these directly into your purchase price calculation, warranty negotiations and contract design.
Save time and resources
Benefit from our bundled expert knowledge instead of coordinating several service providers. One contact person, all expertise from a single source. We take over the analysis of technical documentation, QMS documents, approval documents and vigilance data and provide you with a consolidated assessment that you can use directly for your transaction decision.
Do the products comply with current regulations?
The MDR and IVDR have tightened the requirements considerably. What was permissible under the old directives is often no longer sufficient today. You need to know whether the target company meets the new standards or whether significant rework is required.
What are the costs for compliance production?
Completing technical documentation, carrying out clinical assessments, adapting the QMS – all this costs time and money. Without knowing these costs, you cannot draw up a realistic business case.
Is there a risk of delays in market access?
Expiring certificates, missing notified bodies or incomplete registrations can mean that products cannot be sold for months. Such delays have a direct impact on your sales planning.
Are there hidden liability risks?
Deficiencies in vigilance, unreported incidents or inadequate risk analyses can lead to official sanctions or liability cases. You must be aware of these risks before you become an owner.
We analyze all relevant regulatory aspects of the products and documentation for your target markets. You then receive a clearly structured assessment:
Our services are primarily aimed at medical device manufacturers in various transaction situations. We support manufacturers who wish to have their regulatory status objectively assessed before new investors enter the market or assets are sold. We also support manufacturers who want to expand their existing portfolio or roll it out internationally and need to clarify the regulatory risks of the target products in advance.
In addition, we work for investors and strategic buyers who want to acquire MedTech companies, portfolios or individual product lines and require an independent assessment of the regulatory status. In all these situations, a sound regulatory due diligence reduces valuation uncertainties and prevents unpleasant surprises after deal closing.
In a clearly structured approach, we analyze all relevant regulatory aspects of your target products and target markets. We evaluate the following areas:
Your benefit: Security, time savings and negotiating power
We provide you with certainty for investment decisions: You know the regulatory risks and the actual effort required to establish compliance before you invest. No unpleasant surprises after closing, no hidden additional costs for regulatory improvements.
We help you to avoid delays by identifying bottlenecks at an early stage – for example, expiring certificates, missing clinical data or critical QMS gaps. This information enables you to take countermeasures before the transaction or to realistically plan the timeline for post-merger integration.
Our objective, documented factual basis supports you in determining the purchase price and strengthens your position in negotiations on guarantees, exemptions and purchase price adjustments. You argue on the basis of concrete regulatory facts instead of vague assessments. You benefit from a single point of contact who bundles expertise on EU MDR, IVDR and other relevant markets in an integrated assessment – no time-consuming coordination of several specialists required.
Investment decisions in the MedTech sector raise many regulatory questions. We have answered the most frequently asked questions about procedures, costs and documentation for you. Your question is not listed? Please feel free to contact us.
