{"id":14734,"date":"2025-06-03T15:32:29","date_gmt":"2025-06-03T13:32:29","guid":{"rendered":"https:\/\/hmcgroup.it\/quality-assurance-regulatory-affairs\/"},"modified":"2025-06-04T17:22:55","modified_gmt":"2025-06-04T15:22:55","slug":"quality-assurance-regulatory-affairs","status":"publish","type":"page","link":"https:\/\/hmcgroup.it\/en\/quality-assurance-regulatory-affairs\/","title":{"rendered":"Quality Assurance & Regulatory Affairs"},"content":{"rendered":"\n

Quality Assurance & Regulatory Affairs<\/h1>\n\n
<\/div>\n\n
\"\"<\/figure>\n\n
    \n
  • Danilo Bosetti<\/strong> \u2013 QA\/RA Manager<\/li>\n<\/ul>\n\n

    Team QA<\/p>\n\n

      \n
    • Charlotte Costa<\/li>\n\n\n\n
    • Claudio Tagliavini<\/li>\n\n\n\n
    • Emanuela Govi<\/li>\n<\/ul>\n\n

      Team RA<\/p>\n\n

        \n
      • Glauco Gozzi<\/li>\n\n\n\n
      • Maria Silvia Meschiari<\/li>\n<\/ul>\n\n
        \"\"<\/figure>\n\n

        Team Medicina<\/p>\n\n

          \n
        • Caterina Buono<\/li>\n\n\n\n
        • Shaista Patel<\/li>\n\n\n\n
        • Joanne Schmidt<\/li>\n\n\n\n
        • James Snow<\/li>\n\n\n\n
        • Maria Ziden<\/li>\n<\/ul>\n\n
          <\/div>\n\n

          Quality Assurance<\/h3>\n\n

          Activities<\/h3>\n\n

          Operating since the first ISO certification of the company, the Quality Assurance<\/strong> office manages the company Quality System: a set of procedures, methods, instructions, and registrations relevant to every process in the company<\/strong> (design, production, purchases, sales, maintenance, movement, training etc.). They are designed to execute processes efficaciously and efficiently, by reducing possibility of error and by guaranteeing that the products satisfy the quality and safety requirements.<\/p>\n\n

          The office works with all the other departments and weighs in on the processes, directly or indirectly, by:<\/p>\n\n

            \n
          • Promoting a \u201cQuality Culture\u201d<\/li>\n\n\n\n
          • Solving problems and flaws of products during the manufacturing stages<\/li>\n\n\n\n
          • Management of customer claims<\/li>\n\n\n\n
          • \u2022 Defining methods, procedures, and operative instructions, updating them as needed<\/li>\n\n\n\n
          • \u2022 Defining plans and methods for the quality control of products<\/li>\n\n\n\n
          • \u2022 Qualification and evaluation of Suppliers<\/li>\n\n\n\n
          • \u2022 Management of audits from Customers, Certifying Agencies, Notified Bodies and Competent Authorities (Health Minister in Italy)<\/li>\n\n\n\n
          • \u2022 Management of internal audits<\/li>\n\n\n\n
          • \u2022 Reviewing quality agreements with Customers and Suppliers<\/li>\n<\/ul>\n\n

            Numbers<\/h3>\n\n

            The HMC Premedical <\/strong>Quality Control System has:<\/p>\n\n

              \n
            • 1 Quality Manual<\/li>\n\n\n\n
            • 36 Operating Procedures<\/li>\n\n\n\n
            • 77 Operating Instructions<\/li>\n\n\n\n
            • 120 Attachments and Registration Forms<\/li>\n<\/ul>\n\n

              The HMC Premedical Quality System is ISO certified 13485:2016 by IMQ LTD.<\/strong><\/p>\n\n

              <\/div>\n\n

              Regulatory Affairs<\/h3>\n\n

              Activities<\/h3>\n\n

              The Regulatory Affairs <\/strong>Office is made up of experts in the regulatory framework relevant to the Medical Devices area<\/strong>: they make sure that it is kept up to date and shared with the other departments for the design, production and commercialization of products.<\/p>\n\n

              Among our main tasks, we have:<\/p>\n\n

                \n
              • Verifying and examining the applicable Laws and Regulations, keeping their evolution constantly updated<\/li>\n\n\n\n
              • Supporting all company departments by informing them on the necessary requirements<\/li>\n\n\n\n
              • Analyzing the registration requirements of the Medical Devices in the countries of commercialization<\/li>\n\n\n\n
              • Preparing the files for registration based on the information supplied by the other departments<\/li>\n\n\n\n
              • Preparing the papers required for the CE Certification of Medical Devices<\/li>\n\n\n\n
              • Communicating with the Notified Bodies for CE Certification related activities<\/li>\n\n\n\n
              • Working with other departments on Medical Devices (Risk Management, General Requirements of Safety and Performance, Post Market Surveillance and Post Market Clinical Follow up, Clinical Evaluation, etc..)<\/li>\n<\/ul>\n\n

                Numbers<\/h3>\n\n

                HMC Premedical<\/strong> obtained CE authorizations for:<\/p>\n\n

                  \n
                • 7 Families of I class Medical Devices<\/li>\n\n\n\n
                • 15 Families of Is, IIa and IIb class Medical Devices<\/li>\n<\/ul>\n\n

                  Besides the CE Certification for the European Community, we also registered Medical Devices in the USA, Mexico, Saudi Arabia, and Australia, and we are currently working on several new countries.<\/strong><\/p>\n\n

                  <\/div>\n\n

                  Quality Control<\/h3>\n\n
                  \"\"<\/figure>\n\n
                    \n
                  • Barbara Carnevali<\/li>\n\n\n\n
                  • Sara El Oudini<\/li>\n\n\n\n
                  • Roberta Mantovani<\/li>\n\n\n\n
                  • Marylin Massimo<\/li>\n\n\n\n
                  • Sara Pettazzoni<\/li>\n\n\n\n
                  • Elisa Sprocatti<\/li>\n<\/ul>\n\n
                    <\/div>\n\n

                    Activities<\/h3>\n\n

                    The Quality Control<\/strong> office plans and executes every control established by the procedures and the technical specifications of the products,<\/strong> in all the stages of manufacturing, from raw materials to finished product, and only releasing it to the next phase if compliant.<\/p>\n\n

                    Among the tasks of the Quality Control operators are:<\/p>\n\n

                      \n
                    • Checking materials and finished products arriving from other companies<\/li>\n\n\n\n
                    • Checking the product in every stage of the process: molding, extrusion, automatic and manual assembly, and packaging<\/li>\n\n\n\n
                    • Releasing the product if it complies to the specifications<\/li>\n\n\n\n
                    • Identifying and segregating the non-compliant product to make sure it\u2019s unusable<\/li>\n\n\n\n
                    • Supporting other departments in defining appropriate action to dispose of the non-compliant product<\/li>\n\n\n\n
                    • Supporting the R&D office in the processes of validation.<\/li>\n<\/ul>\n\n

                      To complete these tasks, the Quality Control operators use several measurement tools, such as:<\/p>\n\n

                        \n
                      • A three-dimensional optical measuring system with touch probe<\/li>\n\n\n\n
                      • Profile projectors<\/li>\n\n\n\n
                      • An inline measuring system of the pipe diameter<\/li>\n\n\n\n
                      • A dynamometer for traction and compression checks<\/li>\n\n\n\n
                      • Peel Force Test equipment for packaging<\/li>\n\n\n\n
                      • Leakage under pressure testing equipment (up to 8 bars)<\/li>\n\n\n\n
                      • Digital calipers, micrometers, calibrated spines, Luer ISO 80369-7 swabs, and ENFit ISO 80369-3 swabs<\/li>\n<\/ul>\n\n

                        Numbers<\/h3>\n\n

                        As Quality control, we check and release an average of 100 lots a day, which adds up to 23.000 lots a year, of raw materials,<\/strong> components, and finished medical devices. We sample a representative number of items for every lot, and we do:<\/p>\n\n

                          \n
                        • Paperwork check<\/li>\n\n\n\n
                        • Dimensional checks<\/li>\n\n\n\n
                        • Functional checks<\/li>\n\n\n\n
                        • Visual checks<\/li>\n<\/ul>\n\n
                          \"\"<\/figure>\n","protected":false},"excerpt":{"rendered":"

                          Quality Assurance & Regulatory Affairs Team QA Team RA Team Medicina Quality Assurance Activities Operating since the first ISO certification of the company, the Quality Assurance office manages the company Quality System: a set of procedures, methods, instructions, and registrations relevant to every process in the company (design, production, purchases, sales, maintenance, movement, training etc.). […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-14734","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/hmcgroup.it\/en\/wp-json\/wp\/v2\/pages\/14734","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hmcgroup.it\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/hmcgroup.it\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/hmcgroup.it\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/hmcgroup.it\/en\/wp-json\/wp\/v2\/comments?post=14734"}],"version-history":[{"count":2,"href":"https:\/\/hmcgroup.it\/en\/wp-json\/wp\/v2\/pages\/14734\/revisions"}],"predecessor-version":[{"id":14849,"href":"https:\/\/hmcgroup.it\/en\/wp-json\/wp\/v2\/pages\/14734\/revisions\/14849"}],"wp:attachment":[{"href":"https:\/\/hmcgroup.it\/en\/wp-json\/wp\/v2\/media?parent=14734"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}