Human Repeat Insult Patch Test and Skin Prick Test: FDA and notified body Safety Requirements for Aesthetic and dressing Devices Read More »
How to Select Sites for Diabetic Foot Ulcer (DFU) Studies in Wound Care Medical Device Investigations Read More »
How to Use the FACE-Q Survey to Collect High-Quality Clinical Data for Fillers and PRP Treatments Read More »
Ready to Use AI with Real World Data? What Medical Device Teams Need to Know (and How Milo Can Help) Read More »
Unlocking the Power of Post Market Clinical Follow Up for Orthopaedic Devices with Eclevar Read More »
WEBINAR REPLAY March 25, 2025: Navigating Key Updates to ISO 14155: Driving Clinical Evidence for CE Marking Success Read More »
Empowering CROs: Leveraging Cutting-Edge Technologies for Enhanced Clinical Trial Efficiency and Sponsor Partnerships Read More »
REPLAY WEBINAR : PMCF Under the MDR: Notified Body Insights, Survey Best Practices, and Strategic Implementation Read More »
WEBINAR REPLAY : Unlocking Clinical Insights: Leveraging Level 4 High-Quality Surveys to Address Clinical Data Gaps for Orthopaedic Medical Devices Read More »
Ensuring Data Quality in Global Clinical Trials: The Importance of Linguistic and Form Validation for ePRO Systems Read More »
Key Considerations to Reduce or Address Respondent Burden in Patient-Reported Outcome (PRO) Data Collection Read More »
A Comprehensive Guide to Clinical Investigations with Medical Devices in Europe: Pre- and Post-Market Requirements Read More »
Navigating the Future of UKCA Marking: Key Changes and Strategic Considerations for MedTech Manufacturers Read More »
10 Tips or Criteria for Selecting CROs Running Clinical Trials in Orthopedics and Spine Medical Devices Read More »
Eclevar MedTech and ASAHI INTECC have entered into an agreement to provide consulting expertise in clinical evaluation and post-market clinical follow-up (PMCF) strategies for a Class III vascular catheter device Read More »
GENTELL reaches an agreement with ECLEVAR MedTech for consulting services in clinical evaluation and PMCF strategy. Read More »
Eclevar MedTech and RegenLab entered into an agreement to conduct all upcoming PMCF studies for chronic diabetic foot ulcer devices Read More »
Download Our Case Study: How a Cardiovascular Device Company Surpassed Patient Enrollment Goals by Six Months Read More »
The Integral Role of Contract Research Organization (CRO) Urology in Modern Drug Development Read More »
WHITEPAPER BSI / ECLEVAR EU MDR – POST-MARKET CLINICAL FOLLOW-UP: Gaining Real-world Evidence Read More »
ECLEVAR MEDTECH and Micron Agreed to a Business Alliance in Japan to Provide CRO Services to Medtech Companies Read More »
Decode CER’s Impact on Medical Devices and Master the Art of Choosing Effective PMCF Strategies Read More »
Exploring the vital role of post-market surveillance in ensuring product safety and regulatory compliance Read More »
Facilitating a smooth transition from IVDD to IVDR in the realm of in vitro diagnostic regulation Read More »
PMCF (Post-Market Clinical Follow-up) – An Essential Element of Medical Device Regulation Read More »
ECLEVAR MEDTECH Launches EU Medical Device Regulation Compliance Support Services for Japanese MedTech Manufacturers Read More »
Medical Devices for Cardiac Arrhythmia Management: Clinical Applications and Evidence Requirements Read More »
Accelerating Access to Innovative Digital Medical Devices through Anticipated Reimbursement Read More »
Exploring the Japanese Market? Learn Crucial Insights for Introducing Medical Devices in Japan from a Clinical Perspective Read More »
ECLEVAR is proud to be selected as part of the UK government’s efforts to become a global leader in innovation and high-growth industries. Read More »
MDR 2017/745 Art. 82 Other Clinical investigation with Medical Devices: submissions in Germany Read More »
MedTech Digital Week PMCF Clinical Investigations and Other Studies 04 Oct 2022 – Question and Answers Read More »
Eclevar Australia response to TGA Consultation on proposed regulatory changes for clinical trials of medical devices – 17 August 2022 Read More »
MDCG 2022-5 – Guidance on borderline medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices Read More »
MDCG 2029-9 Rev.1 – Summary of safety and clinical performance A guide for manufacturers and notified bodies Read More »
MDCG 2020-10/1 – Safety reporting in clinical investigation of medical devices under the Regulation (EU) 2017/745 and it’s Appendix MDCG 2020-10/2 Clinical Investigation Summary Safety Reporting Form Read More »
UKCA Mark & Alternative routes to market – a risk or an important step towards global regulation? Read More »
MDCG 2021-28 – Substantial modification of clinical investigation under Medical Device Regulation Read More »
Vigilance reporting Requirements for Manufacturers and Authorized Representatives in Germany Read More »
MDCG Guidance documents summary series: MDCG 2021-20 – Instructions for generating CIV-ID for MDR Clinical Investigations Read More »
PMCF Case Study: Re-Certification of a Long Term Established Legacy Devices in Ophthalmology under MDR- Survey Read More »
Eclevar UK are pleased to announce their first webinar in a series around the UKCA mark and the future regulations. Read More »
