Medavise
Medavise is a company dedicated to supporting the medical device industry through clinical, regulatory, quality, engineering, and technical services. Led by Britt Norton, with a team averaging over 20 years of experience, Medavise provides solutions from strategy development to execution, ensuring compliance and success in bringing medical products to market. The company emphasizes a multidisciplinary approach, operating under strict SOPs, and using best practices to deliver high-quality results. They assist with regulatory pathways, clinical investigations, post-market surveillance, risk management, and more, aiming to help clients navigate complex regulatory landscapes and achieve long-term success.
Industries
Nr. of Employees
small (1-50)
Medavise
Eden Prairie, Minnesota, United States, North America
Products
510(k), PMA, EU, ROW submissions
Regulatory submission services including 510(k), PMA, EU, and ROW.
Clinical investigation
Clinical investigation consulting services for medical devices.
Clinical Evaluation Report (CER)
Clinical Evaluation Report preparation and consulting services.
Post-market surveillance
Post-market surveillance consulting services for medical devices.
Design History File (DHF)
Design History File consulting and management services.
eQMS
Electronic Quality Management System consulting and support.
510(k), PMA, EU, ROW submissions
Regulatory submission services including 510(k), PMA, EU, and ROW.
Clinical investigation
Clinical investigation consulting services for medical devices.
Clinical Evaluation Report (CER)
Clinical Evaluation Report preparation and consulting services.
Post-market surveillance
Post-market surveillance consulting services for medical devices.
Design History File (DHF)
Design History File consulting and management services.
eQMS
Electronic Quality Management System consulting and support.
Services
End-to-end clinical study services including protocol development, EDC selection, site selection and training, ethics submissions, monitoring, statistical analysis and report preparation.
Preparation of complete, evidence-based CERs aligned to EU requirements and relevant guidance documents.
Regulatory pathway selection and preparation support for 510(k), PMA/IDE, EU and other country submissions including generation of filing content.
Design and implementation of QMS aligned to FDA QSR and ISO 13485, including deployment of cloud-based electronic QMS tools and ongoing QMS management support.
Gap analyses and internal or supplier auditing services to assess compliance with regulatory QMS requirements.
Support for user needs capture, product specification development, risk analysis, test method validation and assembly of the Design History File.
End-to-end clinical study services including protocol development, EDC selection, site selection and training, ethics submissions, monitoring, statistical analysis and report preparation.
Preparation of complete, evidence-based CERs aligned to EU requirements and relevant guidance documents.
Regulatory pathway selection and preparation support for 510(k), PMA/IDE, EU and other country submissions including generation of filing content.
Design and implementation of QMS aligned to FDA QSR and ISO 13485, including deployment of cloud-based electronic QMS tools and ongoing QMS management support.
Gap analyses and internal or supplier auditing services to assess compliance with regulatory QMS requirements.
Support for user needs capture, product specification development, risk analysis, test method validation and assembly of the Design History File.
Expertise Areas
- Clinical trial management
- Clinical evaluation report (CER) development
- Post-market surveillance and PMCF
- Regulatory strategy and submissions (US, EU, ROW)
Key Technologies
- Cloud-based electronic quality management systems (eQMS)
- Electronic Data Capture (EDC) systems
- HIPAA-compliant secure cloud storage and encryption
- Systematic review methodologies (PICO, PRISMA)
News & Updates
A discussion on how real-world data from devices already on the market can support foundational research, including recent studies on deep brain stimulation and mapping brain circuits.
Analysis of a tragic Tesla Autopilot crash and its implications for risk management in high-stakes technology, relating to ISO 14971 and residual risk.
Discussion on the relevance of MEDDEV 2.7/1 Rev. 4 guidance for CERs under MDR and the role of MDCG guidance documents.
Exploration of AI in lung ultrasound diagnostics, FDA guidance on AI-enabled device software, and recent research supporting AI-assisted procedures.
Discussion on residual risk, user information, and the responsibilities of device manufacturers under ISO 14971.
A story illustrating the importance of proper testing design and the pitfalls of anecdotal evidence in device safety.
A discussion on how real-world data from devices already on the market can support foundational research, including recent studies on deep brain stimulation and mapping brain circuits.
Analysis of a tragic Tesla Autopilot crash and its implications for risk management in high-stakes technology, relating to ISO 14971 and residual risk.
Discussion on the relevance of MEDDEV 2.7/1 Rev. 4 guidance for CERs under MDR and the role of MDCG guidance documents.
Exploration of AI in lung ultrasound diagnostics, FDA guidance on AI-enabled device software, and recent research supporting AI-assisted procedures.
Discussion on residual risk, user information, and the responsibilities of device manufacturers under ISO 14971.
A story illustrating the importance of proper testing design and the pitfalls of anecdotal evidence in device safety.