Home Clear Cut Thinking Capabilities Contact Us CE MARKING & REGULATORY RAPID CE MARKING FOR FAST PROGRESS TO CLINICAL TRIALS CE MARKING Due to our vast range of CE Marked contact lens designs and materials, using our formal processes we can self-certify CE Marking of products based on predicate devices and clinical evaluations. This allows fast progress to clinical trials that can help determine marketing claims. VALIDATION OF LENS DESIGNS AND PROCESSES The development of a dedicated software suite allows us to validate lens designs, lathe files and processes suitable for CE Mark and FDAÂ approvals. QUALITY CONTROL We have a robust and independent QA sampling and testing environment with a skilled team of technicians. Our team is well acquainted with the measurement of complex designs and experienced in testing new and innovative materials. Quality Management has experience of a wide range of industries and is fully conversant with the optical industry regulatory landscape. INDUSTRY STANDARDS We are conversant with all relevant industry standards and regulations involved inÂ the manufacture, validation and supply of contact lenses and related products. MEDICAL DEVICES 2007/47/EC (93/42/EEC) 2013/473/EU 920/2013 BS EN 1041: 2008 + A1:2013 BS EN 556-1 BS EN ISO 14971 PD CEN ISO/TR 14969 QUALITY SYSTEMS BS EN ISO 9004 BS EN ISO 19011 BS EN ISO 9001 BS EN ISO 13485 BS EN ISO 14001 TOLERANCES BS EN ISO 18369-2 SHELF LIFE BS EN ISO 11987 BS EN ISO 13212 OPTICAL EQUIPMENT & MEASURING SYSTEMS BS EN ISO 18369-3 BS EN ISO 9342-2 BS EN ISO 10012 CONTACT LENSES & CARE PRODUCTS BS EN ISO 14534 BS EN ISO 11986 BS EN ISO 11981 ISO 18259 PD ISO/TS 19979:2014 BS EN ISO 18369-4 BS EN ISO 14729 BS EN ISO 11985 BS EN ISO 12864 STERILISATION BS EN ISO 17665-1 DD CEN ISO 17665-2 PD ISO/TS 17665-3 BS EN ISO 11737-1 BS EN ISO 11737-2 BS EN ISO 10993-1 LABELLING & PACKAGING BS EN ISO 11978 BS EN ISO 15223-1 BS EN ISO 18369-1 +A1:2009 BS EN ISO 11607-1 BS EN ISO 11607-2 SAMPLING SYSTEMS BS 6000:1 BS 6000:2 BS 6000:3 BS 6001-0 ISO 2859-10 BS 6001-1 ISO 2859-1 BS 6001-7 ISO 18414 CLEAN ROOMS BS EN ISO 14698-1 BS EN ISO 14698-2 BS EN ISO 14644-1 BS EN ISO 14644-2 BS EN ISO 11981 QUALITY SYSTEMS BS EN ISO 9004 BS EN ISO 19011 BS EN ISO 9001 BS EN ISO 13485 BS EN ISO 14001 BS OHSAS 18001 CLINICAL BS EN ISO 11980 BS EN ISO 14155 IT SECURITY BS ISO/ IEC 27001 CONTACT US If you have any questions, comments or wish to work with us, please contact us via a method below. ADDRESS Commerce Way, Leighton Buzzard, Bedfordshire LU7 4RW UK PHONE Freephone (UK only): 0800 585115 Tel: +44 (0)1525 381112 Fax: +44 (0)1525 370091 EMAIL info@ultravision.co.uk © 2015 | UltraVision CLPL | Registered in England and Wales No. 1408851 Fatal error: Call to undefined function wp_foots() in /var/sites/c/clpl.co.uk/public_html/wp-content/themes/clpl/footer.php on line 94