{"id":7,"date":"2017-06-22T16:28:42","date_gmt":"2017-06-22T16:28:42","guid":{"rendered":"http:\/\/www.shawquality.ca\/blog\/?page_id=7"},"modified":"2022-11-09T20:17:31","modified_gmt":"2022-11-09T20:17:31","slug":"about-shaw-quality","status":"publish","type":"page","link":"https:\/\/www.shawquality.ca\/blog\/about-shaw-quality\/","title":{"rendered":"About Shaw Quality"},"content":{"rendered":"<h3>Medical Device Experience:<\/h3>\n<ul>\n<li>Michaela Shaw, the principal consultant at Shaw Quality Solutions has over 15 years experience in the medical device Quality Assurance and Regulatory field.<\/li>\n<li>She has participated in dozens of audits so has a deep understanding of auditor expectations.<\/li>\n<li>Works with a diverse group of companies: start-ups, high growth companies and established multi-facility medical device organizations.<\/li>\n<li>Certified Biomedical Auditor trained in ISO 13485, FDA QSR, and MDD requirements.<\/li>\n<\/ul>\n<div class=\"divider\"><\/div>\n<h3>Proven QMS &amp; Knowledge:<\/h3>\n<ul>\n<li>Uses proven Quality Management System templates that have successfully passed dozens of audits<\/li>\n<li>Customizes the QMS to fit company&#8217;s needs (not a boiler plate).<\/li>\n<li>Continues to develop and support the in-house QA team throughout the implementation of the QMS.<\/li>\n<li>Ongoing management of the QMS as the lead of your QA team facilitating the QA functions for design, production and management processes.<\/li>\n<\/ul>\n<div class=\"divider\"><\/div>\n<h3>Flexible Approach:<\/h3>\n<ul>\n<li>As the sole consultant, you receive personal, friendly, on-site attention.<\/li>\n<li>Flexible and Adaptable project plans that are customized for your company&#8217;s development stage, market plan, size and culture.<\/li>\n<li>Multi-Stage approach to QMS Implementation projects:<\/li>\n<\/ul>\n<ol>\n<li style=\"padding-left: 30px;\">Conduct a Gap Analysis<\/li>\n<li style=\"padding-left: 30px;\">Develop a Quality Plan<\/li>\n<li style=\"padding-left: 30px;\">Develop required Procedures and Supporting Documentation unique to your business needs<\/li>\n<li style=\"padding-left: 30px;\">Conduct a Pre-Certification Audit Assessment<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Medical Device Experience: Michaela Shaw, the principal consultant at Shaw Quality Solutions has over 15 years experience in the medical device Quality Assurance and Regulatory field. She has participated in dozens of audits so has a deep understanding of auditor expectations. Works with a diverse group of<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-FullWidth.php","meta":[],"_links":{"self":[{"href":"https:\/\/www.shawquality.ca\/blog\/wp-json\/wp\/v2\/pages\/7"}],"collection":[{"href":"https:\/\/www.shawquality.ca\/blog\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.shawquality.ca\/blog\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.shawquality.ca\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.shawquality.ca\/blog\/wp-json\/wp\/v2\/comments?post=7"}],"version-history":[{"count":0,"href":"https:\/\/www.shawquality.ca\/blog\/wp-json\/wp\/v2\/pages\/7\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.shawquality.ca\/blog\/wp-json\/wp\/v2\/media?parent=7"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}