Medical Device Quality Management Systems | ISO 13485 and FDA QSR Compliant

Our customers have different QMS needs, so we try and provide a variety of QMS configurations that allow our customers to select the best possible solution for gaining ISO 13485:2016, MDR 2017/745, and FDA QSR compliance. Listed below are our BASE, DESIGN, and MANUFACTURING systems along with a content comparison table to help you make an informed decision as to which product is best aligned with your QMS needs.

BASE PLUS QMS PRODUCT

Our BASE PLUS QMS product is a starter package configured to provide customers who develop and manufacture medical devices with ISO 13485:2016 and FDA QSR compliant procedures that address common areas of need.
The BASE PLUS System is a stand alone quality management system configured for companies engaged in the design and manufacture of medical devices who need only the minimum required QMS content  to obtain ISO 13485:2016 certification and FDA QSR compliance.
  • Quality Management System Manual​
  • ​38 Standard Operating Procedures
  • Includes Detailed Forms
  • MS Word and Excel Format​
  • ​Content Audited to ISO 13485:2016 and 21 CFR Part 820 (Multiple Audits)
  • ​ISO 13485:2016, MDR 2017/745 and FDA QSR Compliant
  • ​Digital Content - Instant Download

DESIGN PLUS QMS PRODUCT

Our DESIGN PLUS QMS product are configured to help customer's  engaged in medical device design who need a complete system to obtain ISO 13485:2016 and FDA compliance.
The DESIGN PLUS Quality Management System product is a stand alone quality management system configured to provide medical device design companies with the required procedures needed for ISO 13485:2016 certification and FDA QSR compliance.
  • ​Quality Management System Manual​
  • ​46 Standard Operating Procedures
  • Includes Detailed Forms
  • MS Word and Excel Format​
  • ​Content Audited to ISO 13485:2016 and 21 CFR Part 820 (Multiple Audits)
  • ​ISO 13485:2016, MDR 2017/745 and FDA QSR Compliant
  • ​Digital Content- Instant Download

DESIGN & MANUFACTURING COMBO QMS PRODUCT

Our MANUFACTURING PLUS QMS product is  deep in content and configured for customer's engaged in both the design and manufacture of medical devices who are seeking ISO 13485:2016 certification and FDA QSR compliance.
The MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices, including Software as a Medical Device, seeking ISO 13485:2016 certification and FDA QSR compliance.
  • Quality Management System Manual​
  • ​72 Standard Operating Procedures
  • Includes Detailed Forms
  • MS Word and Excel Format​
  • Content Audited to ISO 13485:2016 and 21 CFR Part 820 (Multiple Audits)
  • ​ISO 13485:2016, MDR 2017/745 and FDA QSR Compliant
  • ​Digital Content - Instant Download

Medical Device Quality Management System Content and Product Comparison Table

Listed below is the content included with each QMS package. An "O" in the applicable cell means the procedure is included.
​ID
PROCEDURE DESCRIPTION
BASE  SYSTEM
BASE PLUS
DESIGN SYSTEM
DESIGN PLUS
MFG
​SYSTEM
MFG PLUS
QMSM
QUALITY SYSTEM MANUAL
O
O
O
O
O
O
4-001
ENGINEERING CHANGE NOTICE PROCEDURE
O
O
O
O
O
O
4-002
DOCUMENT CONTROL PROCEDURE
O
O
O
O
O
O
4-003
RECORD RETENTION PROCEDURE
 
O
  
O
O
O
4-004
EXTERNAL STANDARDS PROCEDURE
 
O
  
O
O
O
4-005
DOCUMENTATION PRACTICES
 
O
  
O
O
O
4-006
SPECIFICATION FORMAT PROCEDURE
 
O
  
O
O
O
4-007
DEVICE MASTER RECORD PROCEDURE
 
O
  
O
O
O
5-001
MANAGEMENT REVIEW PROCEDURE
O
O
O
O
O
O
5-002
ORGANIZATION RESPONSIBILITIES AND AUTHORITY
 
O
 
O
O
O
6-001
TRAINING PROCEDURE
O
O
O
O
O
O
6-002
RESPIRATORY PROTECTION
 
 
  
  
  
O
6-003
BIOHAZARD PROCEDURE
 
 
  
  
 
O
6-004
LOCKOUT / TAGOUT PROCEDURE
 
 
  
  
 
O
6-005
GOWNING PROCEDURE
 
O
  
  
O
O
7-001
DESIGN CONTROL PROCEDURE
O
O
O
O
O
O
7-002
DESIGN REVIEW PROCEDURE
O
O
O
O
O
O
7-003
RISK MANAGEMENT PROCEDURE
O
O
O
O
O
O
7-004
CONTRACT REVIEW PROCEDURE
 
 
 
 
O
O
7-005
PURCHASE ORDER PROCEDURE
 
 
  
 
O
O
7-006
SUPPLIER MANAGEMENT
O
O
  
O
O
O
7-007
IDENTIFICATION PROCEDURE
 
O
  
 
O
O
7-008
RECEIVING PROCEDURE
 
 
  
 
O
O
7-009
CALIBRATION PROCEDURE
O
O
 
O
O
O
7-010
FINISHED GOODS SHIPPING
 
 
 
 
O
O
7-011
LOT INSPECTION PROCEDURE
O
O
  
 
O
O
7-012
PROCESS VALIDATION
O
O
O
O
O
O
7-013
ENVIRONMENTAL CONTROLS
 
O
 
  
O
O
7-014
INSTALLATION QUALIFICATION
O
O
  
O
O
O
7-015
PROTOCOLS AND REPORTS
  
 
O
O
O
O
7-016
PREVENTIVE MAINTENANCE
O
O
  
O
O
O
7-017
FIRST ARTICLE INSPECTION
  
 
  
O
O
O
7-018
CONTROLLED ENVIRONMENT CLEANING
  
O
  
 
O
O
7-019
DEVICE HISTORY RECORDS
O
O
  
  
O
O
7-020
LINE CLEARANCE PROCEDURE
  
 
  
  
O
O
7-021
DESIGN TRANSFER PROCEDURE
O
O
O
O
O
O
7-022
DESIGN CHANGE PROCEDURE
O
O
O
O
O
O
7-023
STERILE LOAD PREP AND RELEASE
  
O
 
  
O
O
7-024
TECHNOLOGY TRANSFER
  
 
 
  
 
O
7-025
RETURNED GOODS PROCEDURE
  
 
 
  
O
O
7-026
SHELF LIFE PROCEDURE
 
 
O
O
O
O
7-027
LABEL REVIEW AND APPROVAL
  
O
O
O
O
O
7-028
PRODUCT PERFORMANCE SPECIFICATIONS
  
 
O
O
O
O
7-029
DESIGN VERIFICATION AND VALIDATION
O
O
O
O
O
O
7-030
DESIGN RISK MANAGEMENT
  
 
O
O
O
O
7-031
PRODUCTION RISK MANAGEMENT
 
O
O
O
O
O
7-032
DESIGN ANALYSIS PROCEDURE
O 
O
O
O
O
O
7-033
SOFTWARE VALIDATION
  
O
 
O
O
O
7-034
BIOCOMPATIBILITY PROCEDURE
  
 
O
O
O
O
7-035
EO STERILIZATION VALIDATION
  
O
 
  
O
O
7-036
GAMMA STERILIZATION VALIDATION
  
O
 
  
O
O
7-037
UNIQUE DEVICE IDENTIFICATION
  
 
O
O
O
O
7-038
CLINICAL EVALUATION
  
 
O
O
 
O
7-039
CLINICAL INVESTIGATION
 
 
O
O
  
O
7-040
CE MARKING PROCEDURE
  
 
O
O
O
O
7-041
INJECTION MOLD VALIDATION 
  
 
 
O
  
O
7-042
USABILITY ENGINEERING
  
 
O
O
 
O
7-043
SOFTWARE AS A MEDICAL DEVICE
  
 
 
O
 
O
7-044
SOFTWARE CLINICAL EVALUATION 
  
 
 
O
  
O
7-045
CLEANROOM DESIGN AND VALIDATION 
  
 
 
  
  
O
7-046
CUSTOMER REQUIREMENTS VALIDATION
  
 
O
O
O
O
8-001
COMPLAINT HANDLING
O
O
 
O
O
O
8-002
COMPLAINT TRENDING
O
O
 
O
O
O
8-003
REMEDIAL ACTION / RECALL
 
 
 
 
O
O
8-004
CORRECTIVE AND PREVENTIVE ACTION
O
O
 
O
O
O
8-005
INTERNAL AUDIT PROCEDURE
 
O
 
 
O
O
8-006
MEDICAL DEVICE REPORT (MDR)
  
  
 
 
O
O
8-007
STATISTICAL TECHNIQUES
O
O
O
O
O
O
8-008
NONCONFORMING MATERIALS
O
O
 
 
O
O
8-009
VIGILANCE PROCEDURE
  
 
 
 
 
O
8-010
PRODUCT HOLD PROCEDURE
  
 
 
  
O
O
8-012
POST MARKET SURVEILLANCE
 
  
 
 
O
O
8-013
PERIODIC SAFETY UPDATE REPORT
  
 
 
  
 
O
8-014
FAILURE INVESTIGATION
  
  
  
O
O
O
 
TOTAL NUMBER OF PROCEDURES
23
38
27
46
60
72
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