Recent & Current Projects
It would be the easiest thing in the world to get testimonials from our clients and list them on the site but we think that’s a little clichéd because they aren’t going to say bad things about us; and if they did it wouldn’t end up on the site!
Instead what we thought would be more interesting would be to provide a list of some recent and current projects to illustrate the variety of projects we undertake for our clients:
- Design dossier review for NASDAQ quoted cardiovascular company
- Multiple 510(k) applications for UK orthopaedic business
- South American international product registrations for UK based female health company
- CE Marking clinical study in three different countries for US based manufacturer of glucose monitoring system
- Multiple clinical evaluations of orthopaedic products for global orthopaedic manufacturer
- Post marketing surveillance study for haemonstatic product in three countries
- ISO 13485:2003 quality system implementation for growing pharmaceutical company developing a solution used as a medical device to reduce tissue adhesion’s after surgery
- CE marking of a novel balloon kyphoplasty device
- Collection of clinical data from 350 patients for inclusion in an submission to US FDA
- CE marking of knee, knee and spinal implants for UK orthopaedics company including project management of all testing, sterilization and packaging
- Regulatory, Design Control and Risk Management support for novel organ preservation system
- Preparation of Design Dossier for American-based manufacturer of a Class III implantable cardiovascular device
- Provision of monitoring support in the UK, for a Regulatory clinical investigation involving a novel urodynamic device for a multi-national company
- Clinical investigation with a manufacturer of a novel cardiovascular defibrillator
- Reimbursement analysis report for a medical device in sixteen European territories
- Ongoing design dossier reviews in specialist areas for a number of Notified Bodies
- Japanese and Chinese product registrations for UK based wound care business
- CE Marking of Drug/Device combination product for US based cardiovascular company
Given we are currently working with over 100 clients this is just a summary of the types of projects we deliver. If your business is medical devices and you need assistance with anything connected with worldwide regulatory, clinical, quality or technical issues we can help!
