{"id":14327,"date":"2019-12-03T17:06:16","date_gmt":"2019-12-03T17:06:16","guid":{"rendered":"https:\/\/oxfordcorp.com\/?p=14327"},"modified":"2023-10-13T16:06:48","modified_gmt":"2023-10-13T16:06:48","slug":"fda-inspection-prep-for-hearing-aid-maker","status":"publish","type":"post","link":"https:\/\/www.oxfordcorp.com\/nl\/insights\/case-study\/fda-inspection-prep-for-hearing-aid-maker\/","title":{"rendered":"FDA Inspection Prep for Hearing Aid Maker"},"content":{"rendered":"

Discover how Oxford promptly provided 15 consultants that were critical to achieving an observation-free site inspection.<\/em><\/p>\n

INDUSTRY<\/strong>
\nMedical Device<\/p>\n

SERVICES<\/strong>
\nInspection Readiness
\nAuditing & Assessment
\nDocumentation<\/p>\n

SKILLS<\/strong>
\nFDA Compliance
\nQuality Management Systems (QMS)
\nMock Inspection<\/p>\n

The Challenge<\/strong>
\nA global market leader in the hearing aid and diagnostics industry received a notification in August that the FDA would be inspecting their manufacturing sites in Denmark for the very first time in November of that same year. Our client requested a team of consultants to visit their facilities and assist with an FDA Inspection Readiness project.<\/p>\n

We previously engaged with this client when they hired an Oxford FDA auditor to assist with inspection readiness audits and mock inspections at other locations.<\/p>\n

The Solution<\/strong>
\nManagement estimated that they would require 15 consultants to work both onsite and remotely on short four\u2013eight week assignments to prepare for the inspection. Within a period of two weeks, we found qualified, available consultants from multiple countries across Europe and arranged for their travel and accommodations.<\/p>\n

Our consultants had to quickly familiarize themselves with the product line and adjust to the local working culture immediately. Their main task was to implement FDA compliance standards into all of the company\u2019s quality documentation, technical files, systems, and processes.<\/p>\n

Oxford\u2019s FDA expert performed a mock inspection at two sites and led the inspection readiness project. The other 14 consultants then focused on several potential weak points, which included software validation, review of SOPs, CFR 820 compliance, ISO 14971\/Risk Management Files, CAPAs, deviations and complaints handling, and Human Factors Engineering.<\/p>\n

The Result<\/strong>
\nWhen the FDA inspection took place, our client received no 483s or major observations. This was a considerable achievement that would not have been possible without the help of the 15 consultants we had placed at very short notice.<\/p>\n

This successful project strengthened our relationship with our client and enhanced our reputation within the tightly knit medical devices community.<\/p>\n","protected":false},"excerpt":{"rendered":"

Discover how Oxford promptly provided 15 consultants that were critical to achieving an observation-free site inspection. INDUSTRY Medical Device SERVICES […]<\/p>\n","protected":false},"author":10,"featured_media":15146,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[181],"tags":[113],"category-tag":[],"class_list":["post-14327","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","tag-life-sciences"],"yoast_head":"\nFDA Inspection Prep for Hearing Aid Maker - Oxford Global Resources<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/fda-inspection-prep-for-hearing-aid-maker\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Inspection Prep for Hearing Aid Maker\" \/>\n<meta property=\"og:description\" content=\"Discover how Oxford promptly provided 15 consultants that were critical to achieving an observation-free site inspection. 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