{"id":20,"date":"2015-09-22T14:11:52","date_gmt":"2015-09-22T14:11:52","guid":{"rendered":"http:\/\/www.biopass.com\/?page_id=20"},"modified":"2021-04-19T17:50:57","modified_gmt":"2021-04-19T17:50:57","slug":"regulatory","status":"publish","type":"page","link":"https:\/\/www.biopass.com\/?page_id=20","title":{"rendered":"About Us"},"content":{"rendered":"\n<figure class=\"wp-block-gallery columns-0 is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\"><ul class=\"blocks-gallery-grid\"><\/ul><\/figure>\n\n\n<p>Biopass Medical Systems located in Coral Springs Florida is\u00a0a contract Medical Device Engineering firm with over\u00a030 years of experience.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-115\" src=\"https:\/\/www.biopass.com\/wp-content\/uploads\/2015\/09\/fda1.jpg\" alt=\"fda\" width=\"195\" height=\"79\" \/>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0<a href=\"https:\/\/www.biopass.com\/wp-content\/uploads\/2021\/04\/ul.png\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone  wp-image-181\" src=\"https:\/\/www.biopass.com\/wp-content\/uploads\/2021\/04\/ul.png\" alt=\"\" width=\"96\" height=\"96\" srcset=\"https:\/\/www.biopass.com\/wp-content\/uploads\/2021\/04\/ul.png 224w, https:\/\/www.biopass.com\/wp-content\/uploads\/2021\/04\/ul-150x150.png 150w\" sizes=\"auto, (max-width: 96px) 100vw, 96px\" \/><\/a><\/p>\n<p>Since 1999 we have developed products for the following companies:<\/p>\n<ul>\n<li>Allen Medical<\/li>\n<li>Aurora<\/li>\n<li>Dental-EZ<\/li>\n<li>Hill-Rom<\/li>\n<li>Nipro<\/li>\n<li>Sentech<\/li>\n<li>Smith &amp; Nephew<\/li>\n<li>Steris<\/li>\n<li>Tridien<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-32\" src=\"https:\/\/www.biopass.com\/wp-content\/uploads\/2015\/09\/ekg-monitor-300x214.jpg\" alt=\"ekg-monitor\" width=\"246\" height=\"175\" srcset=\"https:\/\/www.biopass.com\/wp-content\/uploads\/2015\/09\/ekg-monitor-300x214.jpg 300w, https:\/\/www.biopass.com\/wp-content\/uploads\/2015\/09\/ekg-monitor-1024x730.jpg 1024w\" sizes=\"auto, (max-width: 246px) 100vw, 246px\" \/><\/p>\n<p>Products developed include:<\/p>\n<ul>\n<li>Advanced medication infusion systems<\/li>\n<li>Consumer medical and home healthcare devices<\/li>\n<li>O.R. patient positioning and temperature control systems<\/li>\n<li>In vitro diagnostic devices<\/li>\n<li>Infant incubator controllers<\/li>\n<li>Low-Airloss and Bariatric sleep surfaces<\/li>\n<li>Air-Fluidized beds<\/li>\n<li>Surgical drill and shaver systems<\/li>\n<li>Orthopedic post-surgical therapeutic devices<\/li>\n<\/ul>\n<p><a href=\"https:\/\/www.biopass.com\/wp-content\/uploads\/2015\/09\/reg.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-68\" src=\"https:\/\/www.biopass.com\/wp-content\/uploads\/2015\/09\/reg-300x230.jpg\" alt=\"reg\" width=\"300\" height=\"230\" srcset=\"https:\/\/www.biopass.com\/wp-content\/uploads\/2015\/09\/reg-300x230.jpg 300w, https:\/\/www.biopass.com\/wp-content\/uploads\/2015\/09\/reg.jpg 320w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a><\/p>\n<p>Our ISO 13485 Design Controls include procedures for:<\/p>\n<ul>\n<li>Design Planning<\/li>\n<li>Design Input<\/li>\n<li>Design Output<\/li>\n<li>Design Review<\/li>\n<li>Design Verification<\/li>\n<li>Design Validation<\/li>\n<li>Design Transfer<\/li>\n<li>Design Changes<\/li>\n<li>Design Life Cycle<\/li>\n<li>Risk Management<\/li>\n<li>Software Configuration Management<\/li>\n<li>Software Level of Concern Reporting<\/li>\n<li>Requirements Traceability<\/li>\n<li>Completeness and Accuracy Auditing<\/li>\n<li>Anomaly Reporting<\/li>\n<li>Verification and Validation Summaries<\/li>\n<li>Design Changes For Existing Devices<\/li>\n<li>Software Release procedures<\/li>\n<li>Software Requirements Specifications<\/li>\n<li>Design History File<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>Biopass Medical Systems located in Coral Springs Florida is\u00a0a contract Medical Device Engineering firm with over\u00a030 years of experience. \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Since 1999 we have developed products for the following companies: Allen Medical Aurora Dental-EZ Hill-Rom Nipro Sentech Smith &hellip; <a href=\"https:\/\/www.biopass.com\/?page_id=20\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">About Us<\/span> <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-20","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.biopass.com\/index.php?rest_route=\/wp\/v2\/pages\/20","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.biopass.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.biopass.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.biopass.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.biopass.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=20"}],"version-history":[{"count":12,"href":"https:\/\/www.biopass.com\/index.php?rest_route=\/wp\/v2\/pages\/20\/revisions"}],"predecessor-version":[{"id":184,"href":"https:\/\/www.biopass.com\/index.php?rest_route=\/wp\/v2\/pages\/20\/revisions\/184"}],"wp:attachment":[{"href":"https:\/\/www.biopass.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}