The United States Food and Drug Administration (FDA) recently announced a significant change in its regulatory framework, shifting from the current Quality System (QS) Regulation (21 CFR 820) to a new system known as the Quality Management System Regulation (QMSR). QMSR will go into effect two years after the...
Read moreThe Medical Device Regulation (EU) 2017/745 puts great emphasis on the legal responsibility for the final device being that of the legal manufacturer. However, achieving MDR certification will nearly always depend to some extent on a manufacturer having a dependable supplier; one who knows of the regulatory obligations which...
Read morePlease describe your role As Quality Assurance Manager, I’m responsible for all QA activities at Contamac. I have a great team comprising of our Quality Engineer, QA Technician and QA Administrator, and together we look after the Quality Management System; conducting root cause analysis, implementing corrective and preventive action,...
Read moreODC Industries, a subsidiary of Contamac Ltd, are a medical device manufacturer based in France who produce a variety of products for the ophthalmic industry. We interview Martina Clifford, ODC Industries’ Quality Director to get an overview of her role and the significance of quality assurance in the Medical...
Read moreIn any business, Marketing is key to communicating the products & services we sell to our customers, providing added value and information to allow customers to make the best decision possible. In an ever-changing environment and the continual development in the digital marketing field, it is crucial that marketers...
Read moreIntroduction by Martin Conway In Orthokeratology, the central cornea is flattened by an amount sufficient for the patient to be able to see clearly without lenses. A peripheral ring of power is also created which is approximately equal but opposite to the target refraction i.e. a -3.00 change at...
Read moreOver the last 12 months, Contamac has had the pleasure of welcoming several different groups of visitors from all over the world to meet and participate in tours around our manufacturing facilities. From North America to South America, Europe, Asia and Australasia, we’ve received visits from every corner of...
Read moreCongratulations on your Certificate of Merit for the 2023 Contact Lens Distance Learning course with ABDO. What was your background and experience prior to the course? Thank you so much, it was a real honour to accept the award at the ABDO graduation! I started my journey in 2010...
Read moreIntroduction Acanthamoeba is a free-living unicellular protozoon commonly found in fresh water and soil. The protozoa can be found in two forms: a metabolically active trophozoite and a resistant cyst. Acanthamoeba keratitis (AK) is an infection primarily associated with soft contact lens wearers who demonstrate improper contact lens hygiene...
Read moreBackground Post-surgical ectasia is a complication in which a cornea that has undergone a refractive surgical procedure becomes progressively irregular and thinned leading to protrusion and undesirable visual disturbances such as blur and higher order aberrations. When screening a candidate for LASIK, many factors must be considered to reduce...
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