{"id":41,"date":"2015-01-04T00:41:35","date_gmt":"2015-01-04T08:41:35","guid":{"rendered":"http:\/\/www.smestad.net\/?page_id=41"},"modified":"2020-12-19T12:59:37","modified_gmt":"2020-12-19T20:59:37","slug":"home","status":"publish","type":"page","link":"https:\/\/www.smestad.net\/","title":{"rendered":"Services"},"content":{"rendered":"

Smestad & Associates LLC offer services to support FDA and EU regulatory and compliance needs for medical device companies.\u00a0 We supply reliable, on-target and practical solutions throughout medical device design and development and post-approval phases including regulatory submissions, regulatory compliance and quality.\u00a0\u00a0Smestad & Associates LLC can help guide you to meet the requirements of QSR (21 CFR 820), ISO 13485:2016, ISO 9001:2015, Medical Device Regulation, Medical Device Directive, Japanese Pharmaceutical Affairs Law (JPAL) and Canadian Medical Devices Regulations (SOR\/98-282).<\/p>\n

\n

Design and Development<\/h4>\n

Design Control Implementation
\nDesign Assurance
\nProject Management<\/p>\n

Risk Management<\/h4>\n

Establish risk management programs (ISO 14971:2019)
\nRisk Analyses
\nFailure Modes Effects Analyses
\nLevel of Concern Analyses<\/p>\n

Regulatory Affairs<\/h4>\n

Product strategy
\nRegulatory Submissions
\n510(k) submission preparation and filing
\nResponses to FDA actions
\nRegulatory compliance
\n– responses to FDA and Notified Bodies
\n– preparation for FDA inspections
\nCE Marking
\n– Technical Documentation preparation and submission
\n– MDD\/Medical Device Regulation<\/p>\n<\/div>\n

\n

Quality System Implementation<\/h4>\n

Quality System Regulation (QSR) – 21 CFR 820
\nISO 13485:2016
\nISO 9001:2015
\nMedical Device Directive (MDD)
\nMedical Device Regulation (MDR)
\nJapanese Pharmaceutical Affairs Law
\nCanadian Medical Devices Regulations
\nInternal Audits
\nSupplier Audits
\nFDA Readiness Audits<\/p>\n

Software Validation<\/h4>\n

Software requirements development
\nSoftware validation protocols
\nProtocol execution
\nReport writing<\/p>\n

Facilities, Equipment and Process Validation<\/h4>\n

Installation qualifications
\nOperation qualifications
\nPerformance qualifications
\nSterilization validations<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Smestad & Associates LLC offer services to support FDA and EU regulatory and compliance needs for medical device companies.\u00a0 We supply reliable, on-target and practical solutions throughout medical device design and development and post-approval phases including regulatory submissions, regulatory compliance and quality.\u00a0\u00a0Smestad & Associates LLC can help guide you to meet the requirements of QSR […]<\/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-41","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/pages\/41","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.smestad.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=41"}],"version-history":[{"count":33,"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/pages\/41\/revisions"}],"predecessor-version":[{"id":191,"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/pages\/41\/revisions\/191"}],"wp:attachment":[{"href":"https:\/\/www.smestad.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=41"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}