Combining skilled technical product know-how and regulatory compliance experience, we are able to provide technical medical and health due diligence services to financial investors, strategic investors, consultants, advisory firms and start-up companies. This includes:
- Current product analysis - Analyse and assess existing products for compliance with applicable and anticipated medical devices regulations, directives and standards for current and additional target markets.
- Proposed product analysis - Analyse and assess the expected regulatory requirements applicable in key target markets for new products under development, as well as the estimated timetable for achieving regulatory approval.
- Systems evaluation - Assess a company’s compliance according to the quality management and risk management standards applicable to life science and medical technology companies.
The service will typically include a briefing or workshop to understand the entire set-up and to define project goals. Depending on the need and complexity of each case, an assessment of technical documentation, on-site checks on production infrastructure, competencies and records will be carried out. To ensure confidentiality and non-disclosure of information, a Non-Disclosure Agreement will typically be drawn up. At the end of the project, a technical summary report detailing findings, analysis, assessment of risks will be provided.
TÜV SÜD is uniquely positioned to help companies and investors assess the technical and regulatory factors that contribute to the valuation of life science and medical device technology companies. We are a globally-recognised leader in the testing, inspection, certification and auditing of life science and medical device technologies, helping manufacturers as an independent third party to manage risks as well as protect and promote the health and safety of patients.
TÜV SÜD has established procedures to guarantee independency and objectivity. This allows TÜV SÜD to act as ‘clean teams’ to access in-depth technical product documentation that would not be available to investor’s own due diligence teams because of IP or anti-trust conflicts of interest.
Our world-class laboratories utilise state-of-the-art equipment, and can evaluate products for compliance with international standards and national regulations in every major market. Our global network of more than 400 dedicated medical health and services professionals are supported by our own Clinical Centre of Excellence, and a scientific advisory board comprising of scientists and physicians from leading universities and healthcare centres.