Boca Raton, FL
Sensus Healthcare is pleased to have obtained ISO 13485:2003 certification and CE (Conformité Européenne, which is French for “European Conformity”) mark. As regulatory requirements, standards, and high customer expectations continue to set the bar for medical product manufacturers and their suppliers, Sensus takes pride in its compliance and continued customer satisfaction.
ISO 13485, specifically developed for the manufacture of medical devices, facilitates coordinated medical device regulatory requirements. Its requirements are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.
CE stands for Conformité Européenne, which is French for “European Conformity.” A product in one of the controlled product categories cannot legally be sold in the EU unless it has passed the tests to receive the CE marking.
For a company trying to sell a product, getting a CE marking makes things much easier because it means you can sell the product anywhere in the EU. In the United States, electronic device manufacturers need to meet the same sort of requirements to get FCC approval.
About Sensus Healthcare:
Sensus Healthcare specializes in making proven non-melanoma skin cancer solutions more accessible to patients. Our dedicated superficial radiation therapy (SRT) systems are designed specifically to provide an alternative to surgical procedures for basal cell and squamous cell carcinomas. Our mobile, compact SRT-100™ systems are used widely by oncologists and dermatologists to bring non-melanoma skin cancer treatment to more patients in more settings. We also offer a professional skin care line, Sensus Skin Solutions™, through our physician SRT-100™ users for their patients.
561-922-5808 Ext 108