Clinical investigation and performance study services for medical devices and IVDs
Regulatory requirements for clinical and performance evaluation have become significantly more demanding with the introduction of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). As a result more clinical investigations or clinical performance testing are required as substantiation for conformity assessment.
Medfiles offers comprehensive clinical investigation and performance study services for medical devices and in vitro diagnostic devices (IVDs). With over a decade of experience, we provide both customised solutions and full-service packages – from site and investigator qualification to the clinical study report preparation.
Our services cover the Nordic and Baltic countries, and we also support clinical investigations across Europe through our experienced expert network. Our in-depth expertise in medical devices ensures that your clinical investigations and clinical performance studies meet the latest regulatory expectations, including those set out in ISO 14155 and ISO 20916. Our dedicated SOPs for medical device studies further support high-quality and compliant conduct.
We also offer clinical trial services for medicines and clinical study services for food products.
Free webinar: Medical device clinical evaluation
In this webinar you will learn if your medical device is in a need of clinical investigations. You will also learn about properly documenting a clinical evaluation, including how to compile a clinical evaluation plan and a clinical evaluation report according to the requirements in the MDR. In the webinar we will also give practical tips for ensuring that your clinical investigation meets the needed GCP requirements and none of the essential elements are forgotten.
Read more about our clinical investigation and performance study services:
PROJECT MANAGEMENT IN CLINICAL INVESTIGATIONS
Medfiles will carefully assign clinical project managers (CPM) with proven expertise in clinical investigations to your project. The CPM is the key contact for all parties involved in the clinical investigation or performance study and acts as the key contact between the sponsor and Medfiles.
Our dedicated clinical project managers perform a variety of functions, such as:
- ensuring the progress of the investigation
- serving as the primary resource and point of communication for the sponsor and project team
- effectively utilising our global partners and technical resources, including eCRF, eTMF and EMR providers
- optimising your site selection and feasibility analysis
- leading and managing the project team, including tracking for time schedules, quality and cost of project
- identifying, documenting and mitigating risks early in the process to address potential obstacles
- applying a proactive approach to develop a project team focused on quality and efficiency
- communicating issues and solutions
- projecting “what if” scenarios
- keeping in mind and managing the “big picture” of the trial, the protocol and the sponsor’s objectives
- coordinating and managing the IEC and regulatory submissions.
CLINICAL INVESTIGATION / study SET-UP AND INITIATION
You will receive focused, one-on-one interaction and streamlined, responsive communication with experts who can help you with all aspects of investigation set-up and initiation. Our medical writers can step in already at the study planning stage. Engagement and qualification of professional sites and investigators are crucial elements in clinical investigation. With our large network of trial infrastructure in the Nordic and Baltic areas, we can ensure high-quality performance of sites.
Clinical investigation and performance study planning
- Assistance with study design
- Medical writing for clinical investigation plans (CIPs) or clinical performance study plans CPSP)
- Plan review from regulatory and GCP perspectives
- Consultation on regulatory requirements (local RA) and GCP requirements ISO 14155/ISO 20916
Site identification and qualification
- Principal investigator (PI) and site identification
- Site qualification visits and selection
- Feasibility and qualification documentation
Study initiation
- Project kick-off and investigator meetings
- Trial and organisation registrations, EU portals and ClinicalTrial.gov
- Translations and local adaptations, such as informed consents, study synopsis and patient diaries
- IEC and regulatory submissions
- Study management documents, such as project plans, Trial Master File (TMF ) plans, monitoring plans and safety management plan
- Set-up of eTMF and ISF
- Set up of vigilance activities
- Data management (eCRF planning, set-up and review) and statistical plans
- Site and other vendor contracts and negotiations
- Site initiation visits
- Site staff training and support
CLINICAL INVESTIGATION MONITORING
Medfiles matches the right team to the clinical program of your medical device to ensure the highest quality data review and site support. We have a strong Nordic and Baltic presence and regionally-based clinical research associates (CRAs) in our European network. Our clinical project managers and CRAs are experienced and comprehensively trained, with in-depth knowledge of clinical trial monitoring procedures, regulatory guidelines and a wide range of therapeutic areas.
Assurance of GCP compliance
Monitoring strategy
- on-site and remote monitoring
- centralised monitoring
- uniform practices
- remote evaluation of accumulated data
- risk-based monitoring
- risk evaluation-based monitoring
- dynamic process
- signal detection
- scientific consideration
Trial documents
- collection of essential records
- TMF maintenance
- Agatha eTMF
- ISF review and support
- updates of trial-related plans and instructions
IEC and regulatory updates
- submission of substantial modifications and amendments
- liasion with IEC and other competent authorities
Vigilance
- A(D)E and SA(D)E collection and processing
- development safety update reports
- data and safety monitoring board (DSMB)
- medical coding
- validated safety database
- reconciliation of trial and safety databases
Read more on vigilance services
Data management
END OF CLINICAL INVESTIGATION ACTIVITIES
The most exciting phase of the trial comes once the database is closed and the project is approaching the reporting phase. It is important that both the conduct of the study as well as the obtained results are documented as required from the scientific and regulatory point of view.
- Site close-out visits
- End of study notifications for IEC and regulatory authorities
- TMF delivery
- Vigilance activities
- medical coding (MedDRA)
- Data cleaning, data base lock procedures and statistical analysis
- Clinical investigation reports
- interim reports
- final reports
- tables and listings
- Scientific publications
- Archiving arrangements
Medfiles is a partner that invests in your results and is dedicated to the success of your investigation. By selecting us as your clinical investigation partner, you can be sure that the investigation will be tailor-made, but conducted in accordance with legislation and good clinical practice. Ask for help with individual project stages or the full study solution! See also:
EXPERIENCE – Clinical investigations for medical devices
We have cumulative experience in working with numerous indications and various type of medical devices including IVDs. Our core competence is in clinical investigations on medical devices.
Indications
- Otolaryngology
- Pulmonology
- Wound care
- Orthopedic surgery
- Cancer early detection
- Opthalmology
- Cancer treatment
Type of devices
- Class I, IIa, IIb and III
- Invasive/non-invasive
- Biogradable
- IVD
- Hematology
- Cancer
- Drug-device combination
Extensive experience from various therapeutic areas
WellO2 & Medfiles: good collaboration smooths the path to clinical study success
“Collaboration with Medfiles was smooth in all respects. We felt that our questions were always welcome, and we always received clear and practical guidance, helping us understand what even the things that sounded difficult meant in practice and what we should do in different situations. We were always guided in the right direction along the research path, which ensured successful completion of the investigation.”
clinical team leader
Essi Sarkkinen, Director, Clinical Research and Medical Device
Since joining Medfiles in 2014, Essi Sarkkinen has held several leadership positions. She led the Food, Feed, and Medical Device Regulatory Unit, and later the Clinical Unit. In March 2025, she was appointed Director of Clinical Research and Medical Device.
Essi has a PhD in clinical nutrition and she is adjunct professor at the University of Eastern Finland. Essi has published dozens of scientific articles in peer-reviewed journals and supervised four academic dissertations. After her academic career, she has worked for over 15 years managing and leading contract research in the field of food and nutrition. In the beginning of the 2000s, Essi started working with clinical trials for medicinal products and good clinical practice (GCP), as well as regulatory affairs concerning food product, like health claims and novel foods.
Essi has over 30 years of experience in clinical trials and medical writing as well as know-how of R&D and regulatory affairs in the fields of food, medical devices and pharmaceuticals. All in all, she has worked in various leadership positions in contract research organisations for over 25 years.
insights on medical device AND IVD clinical investigations
Our expert team regularly writes blogs on medical devices and IVDs. Topics include medical device and IVD clinical evaluations and investigations.
Contact us
You may also be interested in:
- Meet our people: From study planning to reporting – 20 years of experience in clinical research and scientific writing
- Why early regulatory involvement accelerates medical device and IVD innovation
- Medfiles contributes to advancing clinical research in Finland through FINCRO
- ISO 14155:2026 – What’s new for medical device clinical investigations?
- How to document IVD performance evaluations under EU IVDR?
- When and how to conduct IVD performance studies under EU IVDR?
- How to gather clinical evidence for IVD performance evaluation under EU IVDR?
- Free webinar: Medical device clinical evaluation – how to document it under the MDR and how to prepare for a clinical investigation?
- When does your medical device need a clinical investigation?
- Guide: How to meet MDR Good Clinical Practice requirements in practice?
- Meet our people: CRA ensuring success of clinical trials
- Planning an investigator-initiated study (IIS)? 10 tips for a successful outcome