Provides resources and a systematic approach to develop and refine a design including preliminary testing and pre-clinical research, all under a design control system. Deliverables may include the following activities and completed documentation:
Software Design and Development Plan (Software DDP)
Product Requirements Document (PRD)
Software Requirements Specification (SRS)
Software Design Specification (SDS)
Risk Management Plan
System Hazard Analysis
Design FMEA (DFMEA)
Prototype Evaluations/Pre-Design Verification Test Results
Material/Component and Assembly Specifications
Preliminary Labeling and Instructions for Use (IFU)
Select ‘Add to Cart’ and Check Out (no payment is required at this stage). You will receive a confirmation email and a member of our team will contact you shortly to provide a custom proposal.
Provides resources and a systematic approach to develop and refine a design including preliminary testing and pre-clinical research, all under a design control system. Deliverables may include the following activities and completed documentation:
Software Design and Development Plan (Software DDP)
Product Requirements Document (PRD)
Software Requirements Specification (SRS)
Software Design Specification (SDS)
Risk Management Plan
System Hazard Analysis
Design FMEA (DFMEA)
Prototype Evaluations/Pre-Design Verification Test Results
Material/Component and Assembly Specifications
Preliminary Labeling and Instructions for Use (IFU)
Select ‘Add to Cart’ and Check Out (no payment is required at this stage). You will receive a confirmation email and a member of our team will contact you shortly to provide a custom proposal.
Includes a documentation package to get you through a Design Development Phase for your product includes procedures and templates for:
Quality System Manual
Document Controls
Quality Records
Management Responsibility
Design Controls
Software Development Life Cycle
Training
Risk Management
