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01Quality 02Manufacturing 03Clinical 04Regulatory 05Supplier 06Product Development 07Postmarket
Quality Solution Overview Document Control Change Control Training Management Corrective Action Deviations Management Nonconformance Out of Specification Audit Management Quality Management Risk Management Spark QMS for Small Business
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Clinical Solution Overview Clinical Management Trial Master File Trial Software Laboratory QMS TMF Checklist
Regulatory Solution Overview Regulatory Information Management (RIM) Submissions for 510(K) and PMA Submissions for eCTD Submissions Management 510K Guidance CTD File
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Development Solution Overview Design Control Change Control Software Change Management Software Change Order Change Management Tool
Postmarket Solution Overview Customer Complaints Medical Device Reporting (eMDR) Complaint Tracking System Complaint Example Device Reporting Software

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01Resources 02FDA 03ISO 04Global
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21 CFR Part 11 21 CFR Part 111 21 CFR Part 1270—1271 21 CFR Part 210—211 21 CFR Part 606 21 CFR Part 820
ISO 9000 ISO 9001 ISO 13485 ISO 14000 ISO 14971 ISO 15189 ISO 17025
TS 16949 CLIA Canadian Standards EU Annex 11

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About Us
About Us

WHAT WE OFFER

01Our Company 02Events 03Become a Partner
About MasterControl Our Core Values Executive Team Mastercontrol In The News Careers Contacts Us
Upcoming Events 2019 Masters Summit Let's Do Lunch
Partner Program Industry Associations

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