Medical Device Quality Management Systems and Procedures
Our medical device quality management systems and individual procedures provide solutions for medical device companies seeking ISO 13485, FDA QSR or MDR EU 2017/745 compliance.
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Biohazard and Waste Disposal Procedure
Regular price $149.00Regular priceUnit price / per -
Calibration System Procedure
Regular price $99.00Regular priceUnit price / per -
Cleanroom Design and Validation Procedure
Regular price $149.00Regular priceUnit price / per -
Cleanroom Procedure Bundle
Regular price $249.00Regular priceUnit price / per -
Clinical Evaluation and Post Market Clinical Follow Up
Regular price $149.00Regular priceUnit price / per -
Clinical Evaluation of Software as a Medical Device
Regular price $149.00Regular priceUnit price / per -
Contract Review Procedure
Regular price $49.00Regular priceUnit price / per -
Control of External Standards Procedure
Regular price $49.00Regular priceUnit price / per -
Controlled Manufacturing Environment Cleaning
Regular price $49.00Regular priceUnit price / per -
Device History Record Procedure
Regular price $149.00Regular priceUnit price / per -
Device Master Record Procedure
Regular price $14.99Regular priceUnit price / per -
Document Control Procedure
Regular price $149.00Regular priceUnit price / per -
Engineering Change Notice Procedure
Regular price $149.00Regular priceUnit price / per -
Environmental Controls Procedure
Regular price $119.00Regular priceUnit price / per -
Ethylene Oxide Sterilization Adoption Protocol
Regular price $199.00Regular priceUnit price / per -
Ethylene Oxide Sterilization Validation Procedure
Regular price $149.00Regular priceUnit price / per -
First Article Inspection Procedure
Regular price $49.00Regular priceUnit price / per -
Gamma Radiation Sterilization Validation and Monitoring
Regular price $149.00Regular priceUnit price / per -
Hazardous Energy Control Lockout Tagout Procedure
Regular price $149.00Regular priceUnit price / per -
Human Factors and Usability Engineering Procedure
Regular price $149.00Regular priceUnit price / per -
Injection Mold Validation
Regular price $149.00Regular priceUnit price / per -
Installation Qualification Procedure
Regular price $119.00Regular priceUnit price / per -
Internal Quality Audit Procedure
Regular price $49.00Regular priceUnit price / per -
Management Review Procedure
Regular price $99.00Regular priceUnit price / per