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

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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

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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

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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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