A Contract Research Organization (CRO) specializing in medical devices plays a pivotal role in supporting the research, development, and regulatory pathways of medical technologies. We at Medtekpartner Research provide a wide range of services to medical device manufacturers, aiming to streamline the complex journey from concept to market introduction. We focus on medical devices and offer expertise and resources that enable manufacturers to navigate regulatory compliance, clinical trials, and product validation more effectively. We act as a strategic partner, contributing to the success of medical device innovations. ​

In essence, we aim to serves as a valuable partner, augmenting the capabilities of medical device manufacturers throughout the development lifecycle. We provide the specialized knowledge, infrastructure, and resources needed to accelerate innovation, ensure regulatory compliance, and bring safe and effective medical devices to market successfully.

We provide services at any development stage​


We can provide help in the early stages of your project to strengthen the foundation, by:

  • Facilitating ideation activities

  • Performing feasibility studies such as preclinical studies, health economics analyses, or formative usability studies

  • Analyzing freedom to operate by patent searches, and help develop your business case


We can assist in all design control stages by:

    • Helping with project planning and implementing design control structure in your project
    • Advise on regulatory strategy (MDR and FDA), medical device classification, clinical investigation strategy
    • Taking charge of your clinical investigation, from planning to reporting. We provide everything you need from site management and monitoring to contact with competent authorities


Post market

We can also provide assistance after your product has reached the market by:

Areas of Expertise​

Your dedicated medical device CRO. ​

Research services

  • Ideation workshops
  • Pre-clinical assessments 
  • Formative usability testing
  • Market analysis
  • Clinical benefit analysis
  • Risk analysis
  • Patent reviews


  • Design control implementation and planning
  • Risk management activities
  • QMS implementation
  • Regulatory strategy MDR and FDA
  • Classification of device or software
  • Compilation of technical documentation


  • Clinical evaluation report
  • Clinical investigation planning
  • Data management and statistics
  • Site management 
  • Study monitoring
  • Medical writing
  • Regulatory submission to ethical committees and IRBs
  • Contact with competent authorities
  • Summative usability testing

General Research Services​

Ideation workshops:

Facilitate early ideation workshops with relevant experts to gather useful insights early in the development process.

Formative usability testing:

Plan and conduct early formative usability analyses and studies with relevant user groups.


Pre-clinical assessments:

Manage all aspects of pre-clinical trials, including protocol writing, site selection, competent authority approval, data management, statistics, data analysis, and report writing.

Health Economics and Outcomes Research:

Conducting studies to assess the economic and clinical value of the medical device.

Clinical investigation strategy:

Provide advice early in the development process to ensure clinical investigation feasibility in later development stages.


Risk Management:

 Identifying and managing risks associated with the device, both during development and post-market.



Patent reviews:

Help with patent application writing and revision, do literature reviews, and early data analysis.

Clinical Research Services​

Clinical Trial Design

Designing and planning clinical trials that meet regulatory requirements and address specific device objectives. 


Clinical Trial Management

Managing all aspects of clinical trials, including site selection, patient recruitment, monitoring, data collection, and safety reporting.


Clinical Investigation Compliance

Ensuring that a study is compliant with Good Clinical Practice and harmonized standards to maintain data integrity and device quality.

Clinical Evaluation

Conduct clinical evaluations and prepare reports in compliance with regulatory requirements.


Biostatistics and Data Management

Handling statistical analysis planning, data collection, validation, analysis, and reporting, to support clinical trial outcomes and regulatory submissions.

Site Management and Monitoring

Conducting site visits to monitor the progress of clinical trials, verify data, and ensure protocol compliance.


Safety and Adverse Event Reporting

Managing the collection and reporting of adverse events and safety data during clinical trials.


Clinical Trial Auditing and Inspections

Preparing for and managing audits and inspections by regulatory authorities.

Medical writing

Help produce Clinical Investigation Plans, Investigators Brochures, Informed Consent Forms, and other required documentation.

Interaction with EC/IRBs and competent authorities

Facilitate submissions of required documentation to ethical committees, institutional review boards, and competent authorities.

Usability Testing

Evaluating the device’s user interface and user experience to ensure safety and effectiveness.

Post-Market Surveillance

Monitoring device performance and safety after market launch, including collecting and analyzing real-world data.

Training and Education

Providing training programs and educational resources related to clinical investigation of medical devices and best practices.

Business Services​

Market Access, Procurement and Reimbursement Strategy

Developing strategies for obtaining market access in the public healthcare sector.​

International Expansion Support:

Assisting with the expansion of the device into international markets by addressing regulatory and cultural differences.

Consulting and Strategic Advisory:

Offering strategic guidance on device development, regulatory compliance, and market access in relation to clinical investigations.

We deliver services at any scope​

Clinical Experts​

Erik Fosse, MD PhD​

Senior Partner / ​Medical Advisor

Erik has a lifelong experience in clinical research, both as a cardiothoracic surgeon and as  head of department at the Intervention Centre at Oslo University Hospital. He has 10 patent applications and has participated in establishing multiple medical companies.

Paul Gordon, PhD​

Senior Partner /​ Clinical Advisor

Paul holds an MSc in pharmacy and a PhD degree in cancer cell biology. He has more than 25 years of experience in clinical trial design, management, and execution with world leading companies.

Magnus Reinsfelt Krogh, PhD​

Head of Research and Development​

Magnus has over 9 years of experience in clinical research, both within academia and the medical device industry. He has led medical device projects through all design control stages and is an expert medical technology scientist with several projects behind him. 

Frode Kristiansen​


Frode has 18 years of clinical experience as a perfusionist and has a total of nearly 30 years of experience in the biomedical field. He has led the development of several different instruments for use in cardiopulmonary perfusion, leading to several published articles and a PhD 

Alexander Stene Moen​


Alexander has over 10 of years experience within the biomedical industry from both the private and public sectors, throughout the whole value chain. He is an expert on strategy, equipment, public procurement, and data analysis.