FDA: New Guidance on remote interactive inspections

Hi auditors!, Here is how FDA (CDER/CBER/CVM) tries to overcome travel restrictions and evaluating us in industry when they cannot do full inspections. If you do remote, you can find interesting information. For example that FDA currently uses Teams, Zoom and Adobe Connect as conferencing platforms! FDA: New Guidance on remote interactive inspections →

Biological and Clinical Evaluations for Medical Devices

Biological and Clinical Evaluations for Medical Devices

a Key2Compliance® Continued Development Conference – Malmö, Sweden October 5-6th The conference supersedes the previous conferences – Symbioteq Biocompatibility of Medical Devices – now organised by Key2Compliance®, a Symbioteq company. The conference has a new format which we hope will suit your medical device needs and is designed to be valuable for both specialists and […]

Welcome Johanna Fondell to our Clinical Development team

The last 8 years Johanna has been working with the Project Management aspect of the studies. This has included overseen different departments and work closely with the Medical Monitors, Clinical Surveillance Team, study Team Leaders, Project Specialist, Data Management and TMF group and ensures everybody has worked as a team together. Johanna believes in good […]

How and when to update your Clinical Evaluation Report (CER)

In general a CER needs to be updated anywhere from at least annually, up to every 5 years, depending on the risk class and how well-established the device is – definately it should be updated after certain trigger events. Learn more about this by watching this video and by taking part in our course “Clinical […]

IVD Performance Evaluation Webinar recording now available

Follow up on free Webinar from March 24th – Performance Evaluation for IVD Medical Devices – How to Reach IVDR Requirements? Maybe not all that registered to attend the live session had the opportunity to take part for one reason or another, so we have made the recording available on our website for you to […]