Experts liaising with regulatory agencies and bodies
Illingworth Research provides regulatory and clinical trial services to the medical device industry where we have extensive experience and knowledge. We acknowledge the different and potentially more complex process within medical device studies, particularly in combinations trials. As a result, we are better able to guide you through the process.
We can provide the following medical device development services:
- Regulatory and clinical trial strategy development
- Preparation of clinical investigation plans
- Project management and trial monitoring
- Data management and clinical trial report preparation
- Liaison with regulatory agencies and notified bodies (NB) and attendance at NB and FDA Pre-IDE Meetings
- FDA, NB and regulatory authority submissions
- Medical device quality assurance
Medical Device Study for a Respiratory Monitor
This exciting study was investigating the use of an oxygen mask equipped with a special sensor that measured respiratory rate using the R8 counter in post-operative recovery of adults and adolescents.
The study enrolled 220 subjects across the UK and was performed within the theatre recovery unit. The site we were working at recruited 75 patients, including 3 adolescents, all having had a general anaesthetic and requiring oxygen post operatively.
The aim of the study was to establish whether measurements of respiratory rate taken using the oxygen mask and R8 counter were equivalent to manual respiratory counting methods in patients receiving oxygen via a face mask. The site we were working at had the highest recruitment rates compared to the other sites.