[vc_row bg_color=”#c3dce7″ top_padding=”100″ bottom_padding=”100″][vc_column width=”1\/1″]
Thanks to our vast experience gained over many years, we can support you in performing your tasks. We will gladly take over even entire spheres of activity from you to completely relieve you of these tasks so that you can concentrate on your other special assignments. This will ensure an effective workflow in your enterprise, and you will have enough time for the tasks requiring your core skills.[\/vc_column_text][vc_column_text] <\/span>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″][vc_column_text]Due to our extensive practical experience, we are your competent partner in:<\/span><\/strong><\/p>\n [\/vc_column_text][\/vc_column][\/vc_row][vc_row bg_image=”17130″ parallax_bg=”true” top_padding=”100″ bottom_padding=”100″ row_id=”part1-en”][vc_column width=”1\/3″][vc_column_text]Quality Management & Quality Assurance<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/span> You can benefit from our hands-on experience in the efficient implementation of the quality management requirements of<\/span><\/p>\n We will also be happy to offer assistance in measures of feedback process optimization, completion of CAPA actions and implementation of change processes.<\/span><\/p>\n \u00a0<\/span>[\/vc_column_text][\/vc_column][vc_column width=”1\/3″][vc_column_text]Technical Documentation & Medical Device Approval<\/strong><\/span><\/p>\n With regard to the approval of your medical devices in Europe, we will provide you with integral support from selecting a notified body through to the preparation of technical documentation to clarifying queries of the notified body arising in the course of reviewing your documents. As to the approvals outside of Europe, our partners are there to help you, especially in the U.S. and in China.<\/span>[\/vc_column_text][\/vc_column][vc_column width=”1\/3″][vc_column_text]Risk Analysis, Risk Management & Usability Engineering<\/strong><\/span><\/p>\n We adhere to EN ISO 14971 in terms of risk management; we will also gladly carry out the PFMEAs for you. It goes without saying that we will provide you with the necessary support in all tasks from the implementation of an efficient risk management process to the preparation of the required proofs. You can also benefit from our experience and problem-solving skills in fulfilling the requirement from usability engineering as per DIN EN 62336-1:2017-07.<\/span><\/p>\n \u00a0<\/span>[\/vc_column_text][vc_column_text] <\/span>[\/vc_column_text][\/vc_column][\/vc_row][vc_row top_padding=”100″ bottom_padding=”100″ row_id=”part2-en” bg_position=”left top”][vc_column width=”1\/3″][vc_column_text]Product Development & Documentation<\/strong><\/span>[\/vc_column_text] Do you have new product ideas or think of re-designing your existing devices? Thanks to our years of hands-on experience, we will make an ideal partner for you and offer you support ranging from the very first feasibility analysis right to the launch of series production. We can relieve you of the entire development process, or take over several selected parts of it. We will provide you with all development steps – from design input through to design outputs, design reviews, design verification and validation to design transfer, and that including documentation – in their entirety according to your specifications in the field of design control of your quality management system. You can also rely on our assistance in preparing design history files, technical documentation and\/or device master records. We can just as well execute the entire range of these tasks for you. In our capacity as your development partner, we use the SOLIDWORKS 3D CAD<\/strong> system. As to optics simulation, we opt for ZEMAX<\/strong>.[\/vc_column_text][\/vc_column][vc_column width=”1\/3″][vc_column_text]Project Management & Project Documentation<\/strong><\/span>[\/vc_column_text] Get us on board, and together we will create a vigilance \/ medical device reporting process customized to your needs. Our expertise is also at your disposal for the implementation of this process. It goes without saying that you can assign the task of medical device reporting to us to a permitted extent. We have many years of experience in the function of PRRC (former: Medical Device Safety Officer), and will be pleased to take this task over from you.[\/vc_column_text][\/vc_column][\/vc_row][vc_row bg_color=”#c3dce7″ top_padding=”50″ bottom_padding=”50″ bg_position=”left top”][vc_column width=”1\/2″][vc_column_text]3D representation of an intraocular lens \u00a0(SolidWorks)[\/vc_column_text][vc_single_image image=”16937″ img_size=”full” css_animation=”fadeIn”][\/vc_column][vc_column width=”1\/2″][vc_column_text]Optics simulation with ZEMAX[\/vc_column_text][vc_single_image image=”16934″ img_size=”full” css_animation=”fadeIn”][vc_column_text] [\/vc_column_text][\/vc_column][\/vc_row][vc_row top_padding=”30″ bottom_padding=”30″ row_id=”prototyping”][vc_column width=”1\/1″][vc_single_image image=”17133″ img_size=”full” alignment=”center”][vc_column_text]Prototyping & small batch production<\/span><\/strong><\/span><\/p>\n From the idea to the ready-to-market product<\/p>\n Your previously simulated product design has been finalized and you would like to take the next development step and implement your idea? We produce your prototypes on our high-precision lathe and milling machines from 3D CAD drawings or optical simulations. With many years of know-how, we support you in creating the necessary programs.<\/p>\n After completing the development process, we would be happy to offer you the opportunity to launch your product in small batch series. We manufacture your product for your from shape cutting to sterilization. During the production process we pay strict attention to the highest quality and documentation.[\/vc_column_text][\/vc_column][\/vc_row][vc_row top_padding=”100″ bottom_padding=”100″ row_id=”part3-en” bg_position=”left top”][vc_column width=”1\/3″][vc_column_text]Clinical Research & Clinical Evaluation<\/span><\/strong><\/p>\n Our experience in the field of clinical research and clinical evaluation of medical devices is primarily focused on ophthalmology. Let us be your partner for all matters of clinical evaluation of your devices – from preparation of clinical evaluation plans through to literature research and monitoring of clinical studies\/trials with your products to preparation of clinical evaluation reports. You can benefit from our expertise in all matters of post-marketing follow-up as well.[\/vc_column_text][\/vc_column][vc_column width=”1\/3″][vc_column_text]Audit Preparation, Support & Procedure<\/strong><\/span><\/p>\n You can benefit from our experience in audit preparation and support according to EN ISO 13485:2016, 21CFR\u00a7820 (U.S. FDA), China FDA as well as Korean FDA. Relieve your own teams of these tasks and assign them to us. You can rely on our support during auditing in the back office; we can, of course, arrange the back office organization for you. We can also assume the task of planning and execution of internal system audits as well as system audits at your suppliers’ including documentation.[\/vc_column_text][\/vc_column][vc_column width=”1\/3″][vc_column_text]<\/p>\n Interim Management & Restructuring<\/span><\/strong><\/p>\n We can look back on up to 20 years of management experience \u2013 from department management to top management of an entire enterprise. This experience is at your disposal for processing your tasks. On the one hand, we can temporarily assume management tasks in the event of staff shortages; on the other hand, we can create restructuring concepts together with you in order to optimize your results, and offer you support in implementing these according to your wishes.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n [\/vc_column_text][\/vc_column][\/vc_row][vc_row bg_image=”16754″ parallax_bg=”true” text_align=”center” top_padding=”170″ bottom_padding=”170″][vc_column width=”1\/1″] [vc_row bg_color=”#c3dce7″ top_padding=”100″ bottom_padding=”100″][vc_column width=”1\/1″][\/vc_column][\/vc_row][vc_row top_padding=”100″ bottom_padding=”100″ bg_position=”left top”][vc_column width=”1\/2″][vc_column_text]The demands on medical device manufacturers are getting more and more complex. Thanks to our vast experience gained over many years, we can support you in performing your tasks. We will gladly take over even entire spheres of activity from you to completely relieve you of these tasks so that you can concentrate on your other special assignments. This will ensure an effective workflow in your enterprise, and you will have enough time for the tasks requiring your core skills.[\/vc_column_text][vc_column_text] [\/vc_column_text][\/vc_column][vc_column width=”1\/2″][vc_column_text]Due to our extensive practical experience, we are your competent partner in: Quality Management & Quality assurance Technical Documentation & Medical Device Approval Person responsible for regulatory compliance (PRRC) acc. MDR Audit Preparation, Support & Procedure Risk Management & Usability Engineering Product Development & Documentation Clinical Research & Clinical Evaluation Project Management & Project Documentation Interim Management & Restructuring [\/vc_column_text][\/vc_column][\/vc_row][vc_row bg_image=”17130″ parallax_bg=”true” top_padding=”100″ bottom_padding=”100″ row_id=”part1-en”][vc_column width=”1\/3″][vc_column_text]Quality Management & Quality Assurance\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 You can benefit from our hands-on experience in the efficient implementation of the quality management requirements of EN ISO 13485 national requirements, e.g. U.S. FDA, Chinese NMPA, Korean MFDS We will also be happy to offer assistance in measures of […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","meta":{"inline_featured_image":false,"footnotes":""},"_links":{"self":[{"href":"https:\/\/amiplant.com\/en\/wp-json\/wp\/v2\/pages\/16285"}],"collection":[{"href":"https:\/\/amiplant.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/amiplant.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/amiplant.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amiplant.com\/en\/wp-json\/wp\/v2\/comments?post=16285"}],"version-history":[{"count":10,"href":"https:\/\/amiplant.com\/en\/wp-json\/wp\/v2\/pages\/16285\/revisions"}],"predecessor-version":[{"id":17166,"href":"https:\/\/amiplant.com\/en\/wp-json\/wp\/v2\/pages\/16285\/revisions\/17166"}],"wp:attachment":[{"href":"https:\/\/amiplant.com\/en\/wp-json\/wp\/v2\/media?parent=16285"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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