{"id":319,"date":"2021-05-26T04:42:52","date_gmt":"2021-05-26T04:42:52","guid":{"rendered":"http:\/\/tech3.mypagedemo.com\/cm-plus\/?page_id=319"},"modified":"2021-06-25T09:12:32","modified_gmt":"2021-06-25T09:12:32","slug":"medical-devices","status":"publish","type":"page","link":"https:\/\/tech3.mypagedemo.com\/cm-plus\/business-fields\/medical-devices","title":{"rendered":"Medical devices"},"content":{"rendered":"

[vc_row animation_type=”fadeIn”][vc_column width=”1\/4″][\/vc_column][vc_column width=”1\/2″][vc_empty_space height=”20px”][vc_custom_heading text=”Medical devices” font_container=”tag:h2|text_align:center|color:%23dd3333″ use_theme_fonts=”yes”][\/vc_column][vc_column width=”1\/4″][\/vc_column][\/vc_row][vc_row][vc_column][vc_btn title=”GMP Consulting” style=”3d” color=”danger” size=”xl” align=”center”][vc_row_inner el_id=”gmp”][vc_column_inner][vc_column_text]CM Plus is a professional consultant for medical device industry. We provide GMP consulting services to industries that must comply with PIC\/S GMP, EU-GMP, cGMP or QSR (US FDA) and WHO-GMP for medical devices. Regulations such as the US FDA 21 CFR Part 820, and the ISO 13485 Quality Management System for Medical Devices and ISO 14971 Risk Management for Medical Devices, etc\u2026 are to be applied.<\/strong>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_btn title=”Facilities Design Reviews” style=”3d” color=”danger” size=”xl” align=”center”][vc_row_inner el_id=”fac”][vc_column_inner][vc_column_text]CM Plus can help you with the design, design review, selection, and installation of facilities and equipment.
\nOur experienced engineers can review your facility design or develop plant designs in conjunction with main construction company(es). They will ensure that you comply with the relevant ISO\/GMP\/GLP guidelines and standards and can interpret them to suit your product type and the markets you supply products to.<\/strong>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_btn title=”Construction and Project Management Services” style=”3d” color=”danger” size=”xl” align=”center”][vc_row_inner el_id=”con”][vc_column_inner][vc_column_text]CMP’s experienced team focused on the delivery of construction and cost management services that range from inspection and valuation to monitoring and control for any construction project. The knowledge understanding of the local regulations, we serve, gives us the ability to deliver services to our clients who value efficiency and consistency. Our service offerings can be broadly classified into Construction and Project Management.<\/strong>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=”cmplus-tabs” animation_type=”fadeInUp”][vc_column width=”1\/4″][vc_custom_heading text=”1. From Gap Analysis to Mock Inspection” font_container=”tag:h4|text_align:center” use_theme_fonts=”yes”][vc_single_image image=”516″ img_size=”full” alignment=”center”][\/vc_column][vc_column width=”3\/4″][vc_column_text]At the First step, if a new GMP like PIC\/S GMP should be additionally applied to a factory in operation, the Man, Machine, Method and Material must be investigated to identify gaps or differences from the relevant GMP requirements.<\/p>\n

CM Plus will investigate and analyze the gaps, and report to the client with a clear proposal on possible countermeasures and a road map for subsequent actions.<\/p>\n

At the Second, a further detailed discussion should be taken place to determine the way to go. In order to facilitate such discussions, CM Plus usually categorizes the gaps into two groups, namely \u201chardware\u201d and \u201csoftware\u201d, and proceeds with discussions with the client to come up with best valued solutions in favor of the client.<\/p>\n

At the Third, according to client\u2019s request, CM Plus will assume responsibilities for execution of engineering and construction. CM Plus will also provide the client with professional support
\nservices to set up proper quality systems with pertinent standard operation procedures (SOP)
\nand GMP training courses for the personnel.<\/p>\n

At last, CM Plus will perform a mock inspection to assure that all of the 4-Ms (Man, Machine,
\nMethod and Material) should be made good for expected inspections by the competent authority.[\/vc_column_text][vc_btn title=”More” style=”modern” el_class=”btn_toggle”][\/vc_column][\/vc_row][vc_row][vc_column][vc_separator color=”juicy_pink”][\/vc_column][\/vc_row][vc_row animation_type=”fadeInUp”][vc_column width=”1\/4″][vc_custom_heading text=”2. Support to build and improve Quality Management System (QMS\/PQS)” font_container=”tag:h4|text_align:center” use_theme_fonts=”yes”][vc_single_image image=”522″ img_size=”full” alignment=”center”][\/vc_column][vc_column width=”3\/4″][vc_column_text]Our consultants can help clients build and reorganize quality management systems (QMS) and
\npharmaceutical quality systems (PQS).
\nThey can also propose an ideal SOP documentation structure based on sound quality assurance policies.
\nThe service also covers documentation support, including Master Batch Records (MBRs) for making reliable and efficient release, and SOPs and other records for assuring high quality manufacturing operations.
\nOutput:
\n– GMP organization,
\n– QMS\/PQS documentation management structures
\n– MBRs (for manufacturing\/packaging), SOPs.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_separator color=”juicy_pink”][\/vc_column][\/vc_row][vc_row animation_type=”fadeInUp”][vc_column width=”1\/4″][vc_custom_heading text=”3. Support to build and improve Laboratory Control System” font_container=”tag:h4|text_align:center” use_theme_fonts=”yes”][vc_single_image image=”174″ img_size=”full” alignment=”center”][\/vc_column][vc_column width=”3\/4″][vc_column_text]The service covers support for building a wide range of quality assurance systems, including management of samples\/reference standards\/reagents, validation of analytical methods, and qualification\/ maintenance\/calibration of test equipment.
\nOutput:<\/p>\n