We pragmatically and efficiently analyse organisational structures and processes as well as medical devices. We conduct the due diligence review according to the client's requirements, in detail or randomly in a snapshot, single- or multi-stage.

 

In M&A transactions in the Medtech Industry, we analyse organisational structures and processes with the aim of providing transparency and ensuring the success of the transaction. Our due diligence provides answers to the following questions:

• How well are the organisational structures and corporate processes documented and how effectively implemented, respectively practised in operational practice?

• How effective, efficient and robust are the organisational structures and business processes?

• How high is the standard compliance of the management system according to ISO 9001, ISO 13485 or FDA 21 CFR part 820 QMSR?

• What is the maturity of the organisational structures and company processes compared to other companies in the branch?

• What opportunities/ value potential and riks does the company have?

• Are there potential deal breakers?

• What organisational measures are necessary after the company acquisition?

 

We also analyse medical devices against the requirements of the European Medical Devices Regulation 2017/745 (MDR), MepV and FDA. This due diligence provides answers to the following questions:

• How compliant are the products with the regulatory requirements?

• What changes need to be made to the products or technical documentation so that they comply with the regulatory or standardisation requirements once the company has been taken over?

• If the conformity assessment with regard to the MDR has not yet been completed, where does the preparatory work stand with regard to the MDR conformity assessment, how well are these documented and are they on target?

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After the acquisition, we support you in integrating the company into your group or reorganising it in line with your strategy and objectives. The knowledge gained from the due diligence check is a valuable basis for determining the necessary measures, which we implement together with you as the new owner and the employees.