December - 202119Stefan Huberso, ALBOMED has a highly successful track record with various international collaboration partners, renowned institutes, clinics, and universities as an Own Brand Label manufacturer. "When our company receives customization requests for specific individual fillings, with all our experience in the viscoelastic field, we gladly say, yes we can," adds Stefan Huber, Head of Sales and Marketing at ALBOMED.Being a DIN EN ISO 13485 certified company, ALBOMED focuses on continuously developing its processes by quickly adapting to market changes, following ever-growing statutory requirements to enable it to offer high-quality viscoelastic medical products consistently. The company's customer-focused QM system was certified in 1997 and has been continuously adapted to the ever-increasing compliance requirements, particularly those concerning CE certification. When working with suppliers and collaboration partners, ALBOMED strongly emphasizes the exact, extremely high-quality requirements that it places on its products and additional compliance standards such as pharmacopeia and GMP. Furthermore, its quality management system is subjected to regular and unannounced internal and external audits. With Europe's new Medical Device Regulation (MDR) set to bring significant regulatory changes in the way medical device manufacturers bring their devices to the market; ALBOMED has already set its course to be ahead of its competitors in complying with the new laws and how they maintain compliance throughout the product's life cycle. The company is working closely with Notified Bodies to ensure a smooth transition to the new regulatory framework. In another significant unforeseen turn of events, COVID-19 has forced companies to respond with immediate changes to meet a surge in demand and ensure the uninterrupted production of necessary devices while keeping workers safe. The rapid spike in demand for medical products has required manufacturers to drastically increase their production capacity in a short amount of time. While business has been stable for ALBOMED, it has efficiently expanded its capacities by opening a new production and logistic site, installed with a fully automatic packaging machine. In terms of new products and solutions for the near future, the company is eager and has plans to launch its much-anticipated product Innoryos shortly. When our company receives customisation requests for specific individual fillings, with all our experience in the viscofield, we say, yes we can
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