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Regulatory Affairs

Avinent looks after every aspect regarding quality, from manufacturing processes, through product safety and functionality, to installations or specific regulations for each country. As such, when an Avinent product arrives at a clinic, laboratory, or hospital anywhere around the world, its quality is always assured.

The manufacturing process

EN ISO 13485: 2016, the regulation for companies manufacturing health products. This quality certificate is renewed every 3 years through annual follow up audits, in our case, by the notifying body, TÜV Rheinland. EN ISO 13485:2016 and the audits are essential aspects to enable manufacturing. The ISO covers the entire product manufacturing process, which includes the company’s supplier evaluations, customer traceability management, and quality control during the production phase.

Product safety and functionality

The EC mark assures product safety and functionality. A stamp that ensures a particular product is safe, irrespective of whether or not it is of medical use. The regulations are currently undergoing changes and the Directive 93/42/EEC is replaced by MDR 2017/745 (Medical Device Regulation), for which Avinent is already taking the required steps. The EC mark is supported by a set of documents and technical files, and in Avinent’s case, covers the different product lines for Avinent Implant System, Avinent CAD CAM, Avinent CMF and Avinent Orthodontics.

Installations

Avinent has a licence for each product line, meaning that they have a licence for the serialised product, Avinent Implant System (approved by the AEMPS), and for the personalised products, Avinent CAD CAM, Avinent CMF and Avinent Orthodontics, all approved by the Catalonia Autonomous Government’s health authority.

International

Every country usually has specific requirements. For example, a technical document has to be presented to market a product in the United States of America. In this case the organisation, the Food & Drug Administration, better known by its abbreviation, FDA, reviews the documentation and either approves or rejects the company starting their commercial activity. Avinent also has the certificates required to operate in other countries, such as Canada, Australia, Japan, Taiwan, Mexico, or Colombia.