Medical devices
In what ways can we be of assistance to you?
In the rapidly evolving landscape of medical devices, we offer comprehensive support for clinical trials and CE certification processes. Our expertise ensures that medical devices meet stringent regulatory requirements, enhancing their safety, efficacy, and market readiness. We are committed to guiding our clients through the entire process, from initial documentation to post-market surveillance, ensuring compliance and delivering high-quality outcomes.
Core services we provide, available in their entirety or partially.
- Documentation Development for CE Certification Process:
- Preparing and facilitating essential documents for the certification of medical devices across all classes (I-III, including implants):
- Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs)
- Risk Analysis in compliance with ISO standards
- Post-Market Surveillance (PMS) and Periodic Safety Update Reports (PSUR)
- Post-Market Clinical Follow-up (PMCF) Plans and Reports
- Summary of Safety and Clinical Performance (SSCP)
- Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER)
- Other technical documentation required for certification and registration, including Instructions for Use (IFUs) and User Manuals.
- Documentation Development for Clinical Trials with Medical Devices:
- Clinical Investigation Plans (CIP)
- Investigator’s Brochure (IB)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR).
- Regulatory Compliance Guidance:
- Providing expert guidance throughout the CE certification process, ensuring all necessary documentation aligns with regulatory authority requirements and enhances market access.
- Medical Monitoring and Oversight:
- Conducting ongoing medical monitoring and risk assessments throughout clinical trials, prioritizing participant safety and ensuring data integrity for reliable outcomes.
- Collaboration and Communication:
- Foster effective communication and collaboration with stakeholders, including regulatory bodies, clinical teams, and project partners, to streamline the certification and clinical trial processes.
- Preparing and facilitating essential documents for the certification of medical devices across all classes (I-III, including implants):
By leveraging our deep expertise in clinical evaluation, regulatory compliance, and medical monitoring, we ensure that medical devices reach the market safely, effectively, and with full regulatory approval. At JO Medical Solutions, we are committed to driving innovation while upholding the highest standards of safety and performance in the medical device industry.