Due diligence in MedTech: Evaluation of organisation, processes, and medical devices

Due diligence refers to the systematic investigation of a company or a product portfolio prior to a strategic decision such as an investment, acquisition, or partnership.

In MedTech, due diligence particularly involves the assessment of three key areas: the organisational structures of a company, the quality and maturity of its internal processes, and the technical and regulatory status of the existing medical devices.

Such an analysis enables a realistic evaluation of how robust existing structures are and what prerequisites are in place for future product development, regulatory approval, and market operations.

Due diligence in MedTech requires a deep understanding of the interdependencies between product development, quality management, and regulatory requirements.

One common focus area is the organisational structure of a company. Responsibilities, decision-making pathways, and the integration of quality-related functions have a direct impact on the stability of development and manufacturing processes.

The analysis of existing processes can also be complex. Development workflows, risk management processes, and product changes must be clearly documented and implemented in a systematic manner. Missing or inconsistent process structures often lead to uncertainty regarding regulatory compliance.

In addition, the actual development status of medical devices plays a crucial role. Technical documentation, risk assessments, clinical evidence, and validation activities must be considered together in order to realistically assess the market readiness of a product.

Our analyses provide a transparent basis for evaluating organisational structures, process maturity, and product status within a company.

A key focus is to assess the effectiveness of internal processes. This includes evaluating whether development processes, quality structures, and regulatory requirements are appropriately aligned and integrated.

In addition, technical documentation and the development status of medical devices are analysed. The objective is to clearly identify strengths, risks, and potential areas for action.

Our services are aimed at investors, corporate groups, strategic partners, as well as MedTech companies that require a well-founded assessment of organisations, processes, or products.

Typical clients include private equity firms and industrial companies in the context of investments, acquisitions, or partnerships. MedTech companies themselves also use such analyses to prepare for financing rounds or for internal positioning and assessment.

Our due diligence services in MedTech include the structured analysis of organisational structures, process landscapes, and medical devices.

Existing documentation, internal processes, and technical evidence are systematically evaluated. The objective is to classify the maturity of a company in terms of product development, quality assurance, and regulatory requirements.

The results are documented in the form of structured assessments and transparent, traceable reports.

Analysis of organisational structures and business processes

• Assessment of the documentation of organisational structures and business processes
• Analysis of the practical implementation and application of these structures in day-to-day operations
• Evaluation of the effectiveness, efficiency, and robustness of key business processes
• Assessment of organisational responsibilities and decision-making structures

Assessment of the management system

• Analysis of compliance with applicable standards within existing management systems
• Evaluation of compliance with ISO 9001, ISO 13485 and/or FDA 21 CFR Part 820 Quality Management System Regulation (QMSR)

Maturity assessment and industry benchmarking

• Assessment of the maturity of organisational structures and business processes
• Positioning of process maturity in comparison to other companies in the MedTech industry
• Analysis of the stability and scalability of existing structures

Risk and opportunity analysis in the context of transactions

• Identification of opportunities and value potential within the organisation
• Analysis of potential risks in organisational structures and processes
• Identification of potential deal breakers in the context of M&A transactions
• Collection of relevant information for planned acquisitions and subsequent integration

Analysis of medical devices and regulatory compliance

• Assessment of the regulatory compliance of medical devices
• Analysis of compliance with Regulation (EU) 2017/745 (MDR), the Swiss Medical Devices Ordinance (MepV), and FDA regulatory requirements for medical devices

Assessment of technical documentation

• Analysis of existing technical documentation
• Evaluation of the status of ongoing MDR conformity assessments and FDA approvals
• Assessment of the quality and traceability of preparatory work
• Identification of required adjustments to products or documentation to ensure regulatory compliance

Organisational measures following a transaction

• Derivation of organisational adjustments following an acquisition
• Identification of necessary structural and process improvements
• Prioritisation of integration measures in the areas of quality and organisational structures

In delivering our services, we apply the relevant legal and normative requirements of the medical device industry, including applicable international standards and regulatory frameworks:

• Regulation (EU) 2017/745  on medical devices (MDR)
• Swiss Medical Device Ordinance MepV 812.213
• ISO 13485 Medical devices –  Quality management systems – Requirements for regulatory purposes
• FDA 21 CFR Part 820 Quality Management System Regulation (QMSR)
• Applicable regulatory requirements for medical devices in CH, EU, USA und UK