MED Institute

?? Exciting News! We are thrilled to announce that we have joined Medical Alley as a service and supplier partner! This partnership reinforces our commitment to advancing healthcare innovation and supporting the development of safe and effective medical devices. ?? Read more about this partnership: https://hubs.ly/Q03cmJLN0 #MedicalDevices #HealthcareInnovation #MedicalAlley #MEDInstitute

? 5 Key Aspects to Successfully Close Out a Device Clinical Study Closing out a clinical study is just as critical as its initiation. Proper close-out ensures regulatory compliance, maintains data integrity, and protects participant safety. MED Institute’s latest blog highlights five essential aspects that every clinical research team should prioritize during the close-out phase: ?? Final Data Review & Validation – Ensuring all data is accurate, complete, and ready for submission. ?? Documentation & Archiving – Properly organizing essential documents for audits and future reference. ?? Regulatory Compliance – Confirming that all necessary regulatory submissions are completed. ?? Site Close-Out & Communication – Ensuring effective communication with study sites and investigators. ?? Dissemination of Results – Sharing findings with relevant stakeholders and participants. A well-executed study close-out safeguards the study’s integrity and paves the way for future success. ?? Read the full blog here: https://hubs.ly/Q03ckk7q0 #ClinicalResearch #MedicalDevices #StudyManagement #RegulatoryCompliance #ClinicalStudies #ClinicalTrials

Attending SOT this week in Orlando? If so, be sure to stop by poster D257 to meet our Senior Regulatory Scientist, Andrea Behling-Agree, PhD, RAC-Devices, RCC(MDR and IVDR)!

Accelerate Your Product Development with MED Institute ?? Bringing innovative medical products to market requires expertise, precision, and a commitment to safety and efficacy. At MED Institute, we’ve spent over 40 years helping clients navigate the journey from concept to commercialization—ensuring their products meet the highest regulatory and quality standards. Let’s work together to bring your vision to life and deliver better solutions for patients. #MedicalInnovation #ProductDevelopment #MedTech #RegulatoryCompliance #MedicalDevice

Are you looking to conduct an in-vivo study, but not sure what that looks like just yet? Here are a few types of studies #MEDInstitute can perform to cater to your needs. Reach out to us here on LinkedIn or on our website via the link below! https://lnkd.in/gZS-dUt5

If you are attending AAOS this week, connect with our Account Manger,?Abby Anttila! She will be onsite today and tomorrow—reach out to discuss how MED Institute can support your organization. Don’t miss this opportunity to meet in person! #AAOS2025

#MEDInstitute can advance your studies through in-vivo & ex-vivo testing. Our team has a wide range of experience with different devices, body systems, and in-vivo models. Reach out to us through our website using the link below! https://lnkd.in/gZS-dUt5

I’m excited to head to Minneapolis for the Medical Alley chat on Thursday with my colleague, Samantha Stevenson, CST/CSFA, CCRP, to represent MED Institute! Let us know if you’re attending!

Successfully completing enrollment for your clinical study – What’s next? Completing clinical study enrollment is a major milestone, but the real work is just beginning! ???? Ensuring a smooth transition into data collection, compliance, and analysis is critical for achieving meaningful results. In our latest blog: https://hubs.ly/Q038Gxnz0, we break down the key steps that follow enrollment, including: ? Regulatory Compliance: Adhering to protocols and ethical guidelines ?? Data Integrity: Accurate and consistent data collection for reliable results ?? Monitoring & Follow-Ups: Ensuring participant safety and engagement ?? Communication & Transparency: Keeping stakeholders informed throughout the study As clinical research continues to advance, staying ahead of these post-enrollment processes is crucial for a successful study outcome. If you're involved in clinical trials, what are your biggest challenges after enrollment? Let’s discuss! ?? #ClinicalResearch #MedicalInnovation #ClinicalTrials #Healthcare #DataIntegrity

?? Key Takeaways on the Draft Guidance on Chemical Analysis for Biocompatibility: Part 2?? The draft guidance on chemical analysis marks a significant leap toward harmonizing analytical procedures and practices across laboratories. This is essential for ensuring accuracy, reliability, and regulatory compliance. In Part 2 of our blog series, we break down: ? Improved analytical methods for volatile, semi-volatile, and non-volatile compounds. ? Emphasis on using appropriate reference standards for robust analysis. ? Clear guidelines for calculating the Analytical Evaluation Threshold (AET) and ensuring traceability. Read part 2 here: https://hubs.ly/Q037mhwk0 At MED Institute, we specialize in providing comprehensive support for chemical analysis and toxicological risk assessments, aligning with ISO 10993-18 and ISO 10993-17 standards. Our team is here to help you navigate these evolving expectations and ensure patient safety while expediting your regulatory submissions. Let's collaborate to foster innovative and safe medical devices! ???? #MedicalDevices #Biocompatibility #ChemicalAnalysis #FDA #RegulatoryAffairs #Toxicology #PatientSafety #Innovation