Mosaic Surgical

Mosaic Surgical is the medical device manufacturing company in the JUNE Medical Group. We improve lives by making surgery safer and easier.

We work with inventors and innovators to bring medical devices to market. One example of this is our Galaxy II Self retraction System (www.junemedical.com) and eVeck.

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 JUNE Medical group of companies.

Company’s Keywords:

medical devices, manufacturing, design, medical devices regulation, iso13485, ce certification, fda approval, clinical evaluation reports, quality systems, technical file preparation, injection moulding