Mosaic Surgical

Mosaic Surgical is located in High Wycombe, United Kingdom on Queen Alexandra Rd. Mosaic Surgical is rated 3 out of 5 in the category medical device manufacturing in United Kingdom. Mosaic Surgical improves lives by providing quality solutions to take medical technologies from invention to commercialisation at cost effective prices. We improve lives by providing cost effective solutions and work with inventors and innovators to bring medical devices to market. One example of this is our collaboration with June Medical to develop the Galaxy II Self retraction System (www.junemedical.com). We work with you to finalise design of the product and take it through the regulatory, quality and clinical requirements for the markets you want to enter such as the EU, US, Canada, Middle East, South Africa, Australia, New Zealand and Asia. Post commercialisation we can continue to provide support for your ongoing requirements such as post market surveillance, maintenance of quality systems, updating clinical evaluation reports, internal audits and assisting with notified body reviews and FDA meetings. Our process includes the following and not all the steps may be applicable or required: 1. Project Scope 2. Regulatory, clinical and quality strategy 3. Design assistance 4. Prototyping & Engineering 5. Medical Injection Moulding 6. Test Production Runs 7. Sterilisation 8. Bench testing/validation 9. Biocompatibility Testing 10. Aging, Packaging & Conditioning testing 11. Co-ordination of clinical activities and ethics approval 12. Submissions, Technical File/Dossier preparation, 510k preparation 13. Certification/ approval by regulatory authorities 14. Delivery of medical devices We provide cost effective flexible solution by people who have been in the industry for decades and who have worked with class I, II and III medical devices. Mosaic Surgical is part of the Mosaic Group.