Due diligence
Our experts in quality and regulatory can strengthen your due diligence team and help you gain insights so you can move forward with confidence.
Due diligence from a quality and regulatory perspective
Stricter regulatory requirements on medical device economic operators (i.e., manufacturers, distributors, and importers) create significant challenges to company acquisitions and investments. Incorporating medical device quality and regulatory expertise into your due diligence team substantially increases the likelihood of a successful transaction.
Our consultants support due diligence projects from a medical device quality and regulatory perspective, either on-site or off-site. We investigate and make objective assessments of medical device businesses, aligned with your specific business objectives. Our service focuses on evaluating the maturity of quality management systems and regulatory compliance of medical devices. Assessments are performed case-by-case against applicable standards and regulations, including ISO 13485:2016, EU Medical Device Regulation (MDR, 2017/745) and FDA 21 CFR Part 820, providing you with a clear view of regulatory and quality-related risks and opportunities.
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Explore our quality and regulatory services
Regulatory strategy
We help you develop an efficient regulatory strategy to meet applicable regulations, mitigate risks, and accelerate time-to-market for your medical device.
Market registrations
Let our team of experts support market registrations of your medical devices in the EU, US and other markets.
Digital health and cybersecurity
Dedicated regulatory and quality experts to help you streamline your medical software development and ensure that you adhere to local and global regulations.
Technical documentation
Expert support in planning, preparing and updating your technical documentation to help you ensure compliance with applicable regulations.
Clinical evaluation
Proven expertise in planning and conducting a thorough clinical evaluation that supports the regulatory approval of your medical device.
Performance evaluation
Dedicated experts in planning and conducting a thorough performance evaluation that supports the regulatory approval of your IVD medical device.
Biological evaluation
We support you in planning and conducting a thorough biological evaluation of your medical device that is compliant with ISO 10993-1.
Risk management
Medical device risk management services for setting up and maintaining your risk management process and helping you prepare your documentation.
Usability engineering
Support for your usability engineering activities, from creating a process to preparing a usability engineering file for your medical device.
Due diligence
Quality and regulatory experts ready to support your due diligence projects with comprehensive appraisals of medical device businesses.
Person Responsible for Regulatory Compliance (PRRC)
Our experts can support you in understanding the full range of PRRC responsibilities.
Quality management system services
QMS services for medical device manufacturers to help you design, implement and manage your QMS to support your organization's needs.
US FDA QMSR
Expert guidance on the US FDA's QMSR and other US regulatory requirements to help medical device manufacturers successfully enter the US market.
Auditing services
Improve your quality management system with our internal auditing services for medical device manufacturers.
Post market surveillance
Post market surveillance services to help you systematically gather and analyze data on the quality, performance, and safety of your medical device.
Our customer-centric approach means that our client’s needs guide our focus to create impactful results.
We prioritize transparency, dependability, and delivering high-quality results.
We deliver agile, tailored solutions through deep expertise and a commitment to excellence.