KEY ASPECTS OF OUR MEDICAL DEVICE DUE DILIGENCE SERVICES
Intended Use Evaluation
We assess whether the intended use of the device addresses an unmet need and evaluate its potential for multiple applications. This includes an early-stage view of clinical relevance, adoption likelihood within the healthcare system, and implications for time-to-market and cost across various regions.
Clinical Evidence Assessment
Our team evaluates whether the device meets regulatory expectations for clinical evidence and whether existing technical evaluation and data support proof of concept and performance claims.
Company Competence Profiling
We examine whether your company has the required technical expertise, pre-clinical development knowledge, and network to bring the device to market. If gaps exist, we help identify where gap analysis and external procurement of services or consultancy may be needed to meet requirements.
Regulatory Strategy Development
We assist in designing and validating a suitable regulatory pathway for your product. This includes reviewing compliance gaps, evaluating the sufficiency of budget and resources, and recommending target markets based on risk classification, documentation needs, and timeline.
Risk Management Analysis
We assess the current state of the art and the technical foundations of the device, identifying possible implementation or design risks. We work closely with your team to develop and document mitigation plans.
Importance of Medical Device Due Diligence
Strategic Decision Making
Thorough medical device due diligence supports critical decisions related to investment, R&D direction, and go-to-market strategy.
Comprehensive Analysis
We provide an integrated view across regulatory, technical evaluation, business, and clinical dimensions—ensuring your product is on a clear path to success.
Identifying Opportunities and Risks
Our analysis identifies potential risks early, but also uncovers growth opportunities, helping align your business with real-world market viability and stakeholder expectations.
WHY CHOOSE MDS FINLAND FOR DUE DILIGENCE SERVICES?
Expertise and Insight
Our team brings deep knowledge of medical device due diligence, regulatory science, and technical and clinical assessment—ensuring a 360-degree evaluation of your project.
Customized Approach
Every evaluation is tailored to your company’s stage, product type, and strategic goals—whether you’re planning procurement, seeking investment, or entering a new market.
Balance of Risk and Value
We provide actionable insights that balance potential barriers with strategic opportunities, empowering your team to take the next steps with clarity and confidence.
FACILITATING INFORMED DECISIONS IN MEDICAL DEVICE DEVELOPMENT
With MDS Finland’s medical device due diligence services, your team is equipped with the insights needed to evaluate readiness, reduce risk, and optimize market viability. Whether for investment, procurement, or internal planning, our due diligence process helps you navigate complexity and position your innovation for long-term success.
