MedTech Results helps Clients meet FDA Quality requirements in a practical, reasonable way. MTR has the expertise to plan and implement medical device Quality Systems per the requirements of the Quality System Regulation, or QSR (21 CFR Part 820). MTR builds Quality systems that conform to ISO 13485:2016 standards and requirements, as well as ISO 14971 (Risk Mgmt), ISO 62304 (Medical Software), and 22301 (Security Management System
MedTech Results develops content for the entire Quality system, including design documentation, master device files, risk analyses, supplier agreements, training materials, Quality Manuals, P&P, etc. MTR also conducts Internal Audits and Management Reviews, as needed. Finally, we can also dig deeper, with expertise in developing quantitative Quality metrics (KPI’s), writing PFMEAs, evaluating software architecture, and investigating Corrective Actions (CAPAs).
Please contact us if your company is planning to seek ISO 13485 certification, or if you are preparing for a Surveillance or Re-Certification audit.