Glossary

• #

  • 21 cfr 1271
  • 21 CFR Part 820

• A

  • Analytical Method Validation

• B

  • Bill of Materials (BOM)
  • Breakthrough Device

• C

  • Calibration review
  • CAPA Management
  • CFR Compliance
  • Cfr Part 11 Compliance
  • Clinical Data Management
  • Clinical Trial Management Systems
  • Compliance Management Software
  • Compliance Risk Assessment
  • Compliance With Gmp

• D

  • Data Integrity
  • Device Master Record

• E

  • Electronic Device History Record (eDHR)
  • Electronic Medical Device Reporting
  • Electronic Medical Device Reporting
  • Electronic Records Management
  • Electronic Signatures
  • Enterprise Document Management
  • Environmental Monitoring
  • EQMS Integration
  • Equipment Maintenance Plan

• F

  • FDA 510k Clearance
  • FDA Audit Trails
  • FDA Warning Letters

• G

  • Good Laboratory Practice (GLP)
  • Good Manufacturing Practices (GMP)
  • GxP Compliance

• I

  • ISO 13485 Requirements
  • ISO 9001
  • iso auditor certification

• M

  • Manufacturing Execution Systems
  • MDSAP
  • Medical Device Inventors
  • Medical Device Labeling
  • Medical Device Life Cycle
  • Medical Device Regulations

• P

  • Performance Calibration
  • Premarket Approval (PMA)
  • Process Verification
  • Product Lifecycle Management
  • Product Management Audit
  • Product Quality Review (PQR)
  • Production Management

• Q

  • Quality Assurance Auditing
  • Quality Assurance Programs
  • Quality management Framework
  • Quality Risk Management (QRM)

• R

  • Regulatory Compliance
  • Regulatory Compliance in Life Sciences
  • Regulatory compliance software
  • Risk-Based Monitoring (RBM)

• S

  • Statistical Process Control (SPC)
  • Supplier Quality Management

• U

  • Unique Device Identification (UDI)

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