We can assist in all design control stages by:
Facilitate early ideation workshops with relevant experts to gather useful insights early in the development process.
Plan and conduct early formative usability analyses and studies with relevant user groups.
Manage all aspects of pre-clinical trials, including protocol writing, site selection, competent authority approval, data management, statistics, data analysis, and report writing.
Conducting studies to assess the economic and clinical value of the medical device.
Provide advice early in the development process to ensure clinical investigation feasibility in later development stages.
Identifying and managing risks associated with the device, both during development and post-market.
Help with patent application writing and revision, do literature reviews, and early data analysis.
Designing and planning clinical trials that meet regulatory requirements and address specific device objectives.
Managing all aspects of clinical trials, including site selection, patient recruitment, monitoring, data collection, and safety reporting.
Ensuring that a study is compliant with Good Clinical Practice and harmonized standards to maintain data integrity and device quality.
Conduct clinical evaluations and prepare reports in compliance with regulatory requirements.
Handling statistical analysis planning, data collection, validation, analysis, and reporting, to support clinical trial outcomes and regulatory submissions.
Conducting site visits to monitor the progress of clinical trials, verify data, and ensure protocol compliance.
Managing the collection and reporting of adverse events and safety data during clinical trials.
Preparing for and managing audits and inspections by regulatory authorities.
Help produce Clinical Investigation Plans, Investigators Brochures, Informed Consent Forms, and other required documentation.
Facilitate submissions of required documentation to ethical committees, institutional review boards, and competent authorities.
Evaluating the device’s user interface and user experience to ensure safety and effectiveness.
Monitoring device performance and safety after market launch, including collecting and analyzing real-world data.
Providing training programs and educational resources related to clinical investigation of medical devices and best practices.
Developing strategies for obtaining market access in the public healthcare sector.
Assisting with the expansion of the device into international markets by addressing regulatory and cultural differences.
Offering strategic guidance on device development, regulatory compliance, and market access in relation to clinical investigations.
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.
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.
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 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 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.