What are the 7 essential areas that should be covered in your Performance Evaluation?
Laura Friedl-Hirst
Managing Director @ LFH Regulatory Limited | Regulatory Affairs I Quality Assurance I Clinical Affairs I UKCA & CE Marking I FDA I QMS I ISO 13485 I Global Registrations
Welcome to our monthly newsletter!
LFH Regulatory is your trusted partner to help guide you through the complex world of Medical Device and In Vitro Diagnostic Regulations.
We know that comprehending the regulatory landscape can be daunting. That is why we are committed to making the process as smooth as possible for you.
This month we'd like to highlight some of our latest stories from our blog, including some professional recognition from the FemTech World Awards 2024.
Read on to find out more.
There are at least seven essential areas that In-Vitro Diagnostic Medical Device Performance Evaluation Reports(PER) should cover...
Under the IVDR Regulation (EU) 2017/746 (IVDR), all IVDs must undergo a Performance Evaluation before being placed on the market. The Performance Evaluation is an important aspect of the IVDR, as it ensures that IVDs are safe, accurate, and effective for their intended use. The requirements on carrying out a performance evaluation plan and report are documented in Annex XIII of the IVDR...
Gender Inclusive Employer award
We are so proud to announce that LFH Regulatory Limited has been honoured with the prestigious Gender Inclusive Employer award by FemTech World.
MedTech Expo '24
The countdown is on for Med-Tech-Innovation Expo taking place on 5-6 June at the NEC in Birmingham. With regulations constantly evolving, we're geared up to guide you through the maze of compliance.
We’re also thrilled to share that our Managing Director, Laura Friedl-Hirst , will be taking the stage at the event. Don't miss her presentation on 'From feasibility through to device launch: When should you consider RA/QA?'
Staff Anniversaries
As we get ready to celebrate our fifth anniversary here at LFH Regulatory, we’re proud to highlight two remarkable members of our team who are also marking their own milestones. Join us in congratulating Helen George , our dedicated Business Manager, on her one-year anniversary, and Josephine Shonaike , our Regulatory Affairs and Clinical Consultant, on her fantastic two years with us. Check out our short Q&A below as they share their experiences and insights!
Industry Insights
MHRA recommends that a Clinical Investigation application includes a separate document is submitted for electrical safety and electromagnetic disturbances (EMD), which is the generic IEC term for both Electromagnetic Compatibility (EMC) and Electromagnetic Interference (EMI). READ MORE
Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behaviour... READ MORE
MDCG 2022-9 / Rev.1 Summary of safety and performance (SSP) Template... READ MORE
MHRA: New action to tackle ethnic and other biases in medical devices... READ MORE
MHRA – Guidance and artificial intelligence (AI) as a medical device... READ MORE
Principles of Labelling for Medical Devices and IVD Medical Devices... READ MORE