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 →

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 […]

IVDR – Literature searches as part of Performance Evaluations

Within a year, IVDR will enter into force and one of the new requirements is performance evaluation of your IVD product, among other things. Johanna Fugelstad and Katalin Holenyi will talk about this and more during a free Webinar on March 24. Do not miss the opportunity – sign up here  Free Webinar on Performance […]

Are your PMCF plan ready for MDR on May 26th?

Do you know that on May 26th this year your medical device company need to have a plan in place for Post-Market-Clinical- Follow-up for every device or device family to comply with MDR?  

Anna Lundén speaking for IDA about Life Science Auditing

The Danish Society of Engineeers – IDA – has invited Anna Lundén from Key2Compliance® to speak on their continues knowledge upgrade program – IDA Upgrades. The topic today is – Life Science Auditing – challenges and possibilities. The session has attrackted some 90 interested IDA members and Anna will amongst other things touch the subjets […]

LMV informerar om kliniska prövningar relaterat till MDR

Hur vet jag om en studie är en klinisk prövning av medicinteknisk produkt? Läkemedelsverket har tagit fram en film för att förtydliga vilka kliniska studier som omfattas av bestämmelserna i det nya regelverket om medicintekniska produkter.

Welcome Mia Rinde to our Clinical Development team

Mia Rinde joins the clinical development team as a medical writer and information specialist working primarily with clinical evaluations. She is into systematic literature reviews and has a passion for detail. Mia holds a licentiate degree in physiology from Stockholm University where she performed preclinical studies on a prospective medical device targeting diabetes.