In the medical devices sector, safety and quality are two non-negotiable values companies need to bring to the table. Our experience in developing components for medical equipment manufacturers allows us to provide our customers with products that meet the regulatory requirements.
Our customers rely on Melrose’s ISO 9001:2015 and AS9100D certification (aerospace).Melrose has regular customer audits that confirm that Melrose is compliant with the non-skin contact portions of ISO 13485. The products covered by this audit include silicone keypads, membrane switches, graphic overlays, labels, electronic displays and touchscreens.
At Melrose, we know how to manufacture components that address the unique needs of the applications developed by our clients. Our teams engineer products for infusion pumps and other applications used in clinical, hospital, and dental settings.
Membranes and graphic overlays for the medical industry
Melrose is an expert medical membrane switch and graphic overlay supplier. Our components are FDA-approved and meet the relevant medical ISO standards.
Our biocompatible overlays are rated USP Class VI and are FDA-approved for the following tests: systemic toxicity, intracutaneous, toxicity, implantation, cytotoxicity, hemolysis, pyrogenicity, sensitization, and physicochemical testing.
Moreover, our graphic overlays and medical membrane switches have been qualified for the cytotoxicity and skin irritation requirements of ISO 10993.
Certification that guarantees quality
We also comply with AS9100D and ISO 9001:2015 as the manufacturer of: