Due Diligence for Medical Devices and IVDs
When you’re considering acquiring a Medical Device or IVD company, due diligence becomes your most important tool for making a smart, safe investment. It’s like getting a full health check-up on the company before you commit – ensuring everything is in good shape and there are no hidden issues that could cause trouble later.
From a customer or buyer’s perspective, due diligence helps you confirm that the company you’re acquiring complies with the strict requirements of the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).
This means checking that their products are properly classified, that they have the right CE markings, and that all technical documentation and clinical evidence are complete and up to date. You also want to make sure their quality management system is robust and that they’re actively monitoring product performance and safety after the devices are on the market.
This process protects you from unexpected regulatory problems, such as non-compliance that could lead to product recalls, fines, or even losing market access. It also gives you a clearer picture of the company’s true value—because a business that’s fully compliant and well-documented is worth more and carries less risk.
In short, due diligence helps you make sure you’re buying a company that’s not only innovative but also safe, legal, and ready for long-term success in a regulated industry.
We guide you through the process, checking that everything is compliant.