FDA QSIT Mock Inspections
The FDA Quality System Inspection Technique (QSIT) audit is indispensable for US market compliance, focusing on critical quality system components.
At Apotech, our FDA QSIT audits closely emulate real FDA inspections. We examine your QMS through the lens of the FDA’s inspection framework, providing clear insights and identifying gaps.
Trusted by top-tier teams worldwide
Our expert auditors — with technical backgrounds and proven regulatory success — will thoroughly assess your processes, especially around:
- Design controls
- CAPA
- Manufacturing controls
- Complaint handling
This tailored approach prepares your team for real FDA inspections and reduces risk during commercialisation in the US.
Featured case studies
Prosthesis manufacturer
Prosthesis manufacturer Introduction As part of their international development strategy, our client wanted to get MDSAP certified with a focus on Canada, Australia and Brazil. They were MDSAP certified within 7 months. Types MDSAP Audit Preparation, Quality Management System Review Scope of work Selecting the certification body (quotes, Q&A) Review of their quality management system…
Quarterly Internal Audits
Quarterly Internal Audits Introduction Quarterly Internal Audits Our client is a start-up medical device manufacturer of a body cooling device, for those with heat stroke. They are based in the UK and are undergoing ISO 13485 certification. Standards & Tools 21 CFR ISO 13485 MDSAP MDR Scope of work Key numbers Excited to work together…