Since the start of lockdown MHRA has now carried out over 750 inspections conducted remotely across the Good Practice Standards (GxPs), a huge achievement given both the pandemic restrictions and also juggling with caring and childcare responsibilities, both on the part of the inspectors and those we are required to inspect. Blog – MHRA Inspectorate →
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 →
New Release – ISO 20417:2021(en) Medical devices — Information to be supplied by the manufacturer. This document provides the requirements for the identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. We can help review the labeling of your products and other product […]
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 […]
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 […]
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 […]
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?
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 […]
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.
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.