MEDICAL DEVICES · DIAGNOSTICS · COMBINATION PRODUCTS
Strategic expertise for MedTech, Diagnostics and Pharma
Foundtri provides senior regulatory, quality and product development consulting across the product lifecycle from early development to post-market.
At the same time, technology is reshaping expert work. Foundtri takes an active role in that transition by developing practical approaches to recognizing, connecting and strengthening expertise.
HOW WE CAN SUPPORT
What does your project need?
Whether you need advice on a critical regulatory decision, hands-on support with documentation or quality, or experienced leadership for a demanding project, Foundtri brings the expertise to move the work forward.
Regulatory strategy & registrations
Technical Documentation & Dossiers
Capability Management
Post Market &
Lifecycle
Quality & Compliance
Strategic Roles & Project Leadership
WHO WE WORK WITH
Expertise across regulated healthcare
Foundtri works across MedTech, diagnostics and pharma,
from manufacturers and pharmaceutical companies to importers, distributors and Notified Bodies.
We are particularly well placed to support you in projects
where products, regulatory frameworks and quality systems intersect.
Medical Device & IVD Manufacturers
Regulatory, quality and product development expertise for medical device and IVD manufacturers, with particular strength in non-active, substance-based and pharma-connected products
Pharmaceutical Companies
Combination products, device-drug interfaces and diagnostics expertise for pharma teams working across pharmaceutical and medical device requirements
Importers & Distributors
Practical regulatory and quality expertise for medical device and IVD importers and distributors operating under MDR and IVDR economic operator requirements
Notified Bodies
Specialised expertise and project support for Notified Bodies, combining hands-on assessment experience with regulatory, quality and organizational development expertise
MEET THE FOUNDER
Tiina Riihimäki, PhD
Founder & Principal Advisor
More than 15 years across regulated healthcare from research and industry to Notified Body work and consulting.
I have worked across medical devices, diagnostics and pharmaceuticals, supporting organizations ranging from global companies to early-stage start-ups. My experience spans regulatory affairs, quality and product development, grounded in European regulation and strengthened through international projects.
This breadth is particularly valuable when a project crosses functional or regulatory boundaries. It allows me to connect regulatory strategy, the quality system, product development and organizational realities, seeing not only the individual elements, but how they affect one another.
SELECTED EXPERIENCE & INVOLVEMENT
- Notified Body experience – lead auditor, technical, preclinical and clinical assessor roles;
- Team-NB and MDCG mirror working group participation
- Lead auditor – ISO 13485 and ISO 9001
- Scientific background – PhD in medical technology
- European regulatory expertise – MedTech, IVD, combination products and regulatory interfaces
- Product development – regulatory and quality integrated into design and development
- Leadership – global projects, team leadership and EMEA-level business development
- Professional & industry involvement – Chair of the IVD Working Group at Healthtech Finland; speaker at RAPS and TOPRA events; contributor to pharmaceutical and pharmacovigilance events
Let’s connect on LinkedIn!
WHY FOUNDTRI?
Building the future of expert work
Many organizations face a practical challenge: regulatory and quality requirements overlap, while the expertise needed to address them is not always available in one place. In large companies and consulting firms, expertise can become fragmented across functions and teams. In smaller companies, a few people may need to cover a very broad range of responsibilities without access to specialist expertise in every area.
The most demanding projects often arise at the intersection of regulatory strategy, quality and product development, particularly when multiple regulatory frameworks apply. Foundtri was created to work across these boundaries, bringing together the right expertise, maintaining a clear strategic overview and providing continuity throughout the project.
Expert work itself is changing. Technology is reshaping how information is accessed, connected and used and how expertise is built and applied. This creates an opportunity to rethink how organizations recognize expertise, make it visible and continuously strengthen it.
Our work brings these two perspectives together: senior regulatory, quality and product development expertise for your projects today, and practical approaches to strengthening expert capability as technology reshapes the work.
FOUNDTRI EXPERT NETWORK
The expertise
complex work demands.
The Foundtri Expert Network brings together selected senior professionals with deep experience across regulated healthcare. It allows us to complement our core expertise when a project calls for additional depth, in biological safety, clinical evaluation, usability or regulatory requirements beyond Europe, including the US.
The network combines long-standing industry experience with perspectives from professionals who have worked within Notified Bodies and regulatory authorities.
Would you like to connect with the network?
Are you an experienced professional working independently or considering freelance work, or are you looking for mentorship as you develop your career?
The Foundtri Expert Network offers opportunities to contribute to selected assignments, collaborate with fellow professionals and stay connected with the wider regulated healthcare community. As expert work evolves, the network creates a place for expertise to be shared, developed and connected across professional boundaries.
Q&A
Questions that keep coming up
In practice, the most challenging questions tend to arise where requirements overlap, guidance is limited or changing, or different fields approach the same issue from different perspectives.
How much time should I plan for medical device EU conformity assessment?
Until now, Notified Bodies have largely defined their own conformity assessment processes and timelines. Commission Implementing Regulation (EU) 2026/977 introduces new requirements, including maximum timelines for key steps of the assessment, which will mainly apply from 25 February 2027. Actual timelines and working practices will still depend on the device and the assessment required and should be discussed with the Notified Body.
Can a PRRC be located outside the EU?
Yes. For a non-EU manufacturer, the PRRC can be located outside the EU and should have a close and continuous link with the manufacturer. For an EU Authorised Representative, the PRRC must be located in the EU.
Does the MDR always require a clinical investigation for a medical device?
No. The MDR requires a clinical evaluation, but this does not automatically mean that a new clinical investigation is needed. The starting point is to evaluate the available clinical evidence against the device’s intended purpose, claims, safety and performance requirements and the current state of the art. Only then can you determine whether the existing evidence is sufficient or whether additional clinical data including, where necessary, a clinical investigation, is needed.
Do I have sufficient clinical data for my medical device?
It depends on what you need the clinical data to demonstrate. Clinical evaluation considers the totality of available clinical evidence against the device’s intended purpose, claims, safety and performance, and the current state of the art. The question is therefore not simply how much clinical data you have, but whether the evidence is appropriate and sufficient to support the device and its claims.
Foundtri can help assess the available clinical evidence, identify potential gaps and determine what additional evidence may be needed.
Are eye drops a medical device or a medicinal product?
They can be either. To qualify as a medical device, the product must have an intended medical purpose. The key question is then how the product achieves its principal intended action. If that action is pharmacological, immunological or metabolic, the product falls under medicinal product legislation. If the principal action is achieved by physical or other non-pharmacological means, it may qualify as a medical device. The intended purpose, mode of action, formulation and supporting scientific evidence therefore need to be considered together.
Foundtri can help assess whether your product may qualify as a medical device and identify the appropriate regulatory route.
Is a nasal swab used for a COVID-19 test a medical device or an IVD?
The swab itself is a medical device under the MDR, not an IVD. Because it is applied directly to the human body to collect the specimen, it falls under the MDR. The diagnostic test that examines the collected specimen is regulated under the IVDR.
Does the concentration of a substance determine whether a product is a medical device or a medicinal product?
Not by itself. Under the MDR, there is no general concentration threshold that determines whether a product is a medical device; the principal mode of action remains key. From the medicinal product perspective, however, the amount or concentration of a substance can be relevant when assessing whether it produces a pharmacological action. The assessment therefore needs to consider both regulatory frameworks and the scientific evidence for the product’s mode of action.
How is a wound dressing containing silver or an antibiotic regulated in the EU?
It depends on the role of the substance. If the dressing achieves its principal intended action as a medical device and the medicinal substance has an ancillary action, the product can be regulated under the MDR. If the substance provides the principal action, the product may instead fall under medicinal product legislation. A medical device incorporating an ancillary medicinal substance is classified as Class III and requires the applicable medicinal substance consultation as part of conformity assessment.
When does a variation to an integral drug-device combination require an updated Notified Body Opinion?
Not every variation requires an updated NBOp. The MAH should assess whether the change affects the device part or its compliance with the relevant GSPRs and whether a new or updated NBOp is needed. The appropriate approach also depends on whether there is an ongoing contractual arrangement with the Notified Body covering lifecycle changes.
Foundtri is happy to support your company on the variation assessment and discussions with Notified Body.
Does the device part of an iDDC need to follow MDR post-market surveillance requirements, or is pharmacovigilance sufficient?
An iDDC is regulated as a medicinal product, so post-authorisation safety monitoring follows the applicable pharmacovigilance framework. However, device-related safety, performance, malfunctions and complaints still need to be appropriately captured and assessed. In practice, the pharmacovigilance and device-related processes need to work together so that relevant information from the device part is not lost.
Foundtri can help adapt existing pharmacovigilance processes and systems to incorporate the necessary device-specific elements.
Are IVDR Article 5(5) requirements for an in-house CDx the same across all EU countries?
Not entirely. Article 5(5) provides the EU framework for in-house IVDs, but national requirements and interpretations also need to be considered. These may affect, for example, health institution requirements, laboratory accreditation, notifications and competent authority oversight. For a CDx used in multinational oncology drug development, the in-house route should therefore be assessed for each country involved.
Foundtri can help assess Article 5(5) requirements and the appropriate in-house CDx strategy for multinational drug development programmes.
Does an EU medical device distributor need an ISO 13485 quality management system?
No. MDR Article 14 sets specific requirements for distributors, including verification, documentation, storage, traceability and handling of complaints and non-conforming devices, but it does not require ISO 13485 certification. ISO 13485 can, however, provide a recognised framework for building a compliant distributor QMS. Additional QMS requirements apply to certain relabelling and repackaging activities under Article 16.
Would you like to start a project with us?
Bring us the challenge. We add the strategic expertise that helps unlock the next step.