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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Medical Device Complaint Trending Procedure
Regular price $99.00Regular priceUnit price / per -
Medical Device Complaint Handling System
Regular price $149.00Regular priceUnit price / per -
Record Retention Procedure
Regular price $49.00Regular priceUnit price / per -
Medical Device Failure Investigation Procedure
Regular price $149.00Regular priceUnit price / per -
Medical Device Periodic Safety Update Report Procedure
Regular price $149.00Regular priceUnit price / per -
Medical Device Post Market Surveillance Procedure
Regular price $149.00Regular priceUnit price / per -
Medical Device Product Hold Procedure
Regular price $149.00Regular priceUnit price / per -
Medical Device Vigilance Procedure
Regular price $149.00Regular priceUnit price / per -
Medical Device Nonconforming Material Procedure
Regular price $149.00Regular priceUnit price / per -
Statistical Techniques Procedure
Regular price $149.00Regular priceUnit price / per -
Medical Device Reports Procedure
Regular price $149.00Regular priceUnit price / per -
Internal Quality Audit Procedure
Regular price $49.00Regular priceUnit price / per -
Medical Device Corrective and Preventive Action Procedure
Regular price $149.00Regular priceUnit price / per -
Medical Device Remedial Action Recall Procedure
Regular price $149.00Regular priceUnit price / per -
Cleanroom Design and Validation Procedure
Regular price $149.00Regular priceUnit price / per -
Clinical Evaluation of Software as a Medical Device
Regular price $149.00Regular priceUnit price / per -
Software as a Medical Device Development Procedure
Regular price $149.00Regular priceUnit price / per -
Human Factors and Usability Engineering Procedure
Regular price $149.00Regular priceUnit price / per -
Medical Device CE Marking Procedure
Regular price $149.00Regular priceUnit price / per -
Medical Device Clinical Investigation Procedure
Regular price $199.00Regular priceUnit price / per -
Clinical Evaluation and Post Market Clinical Follow Up
Regular price $149.00Regular priceUnit price / per -
Unique Device Identification Procedure
Regular price $149.00Regular priceUnit price / per -
Gamma Radiation Sterilization Validation and Monitoring
Regular price $149.00Regular priceUnit price / per -
Ethylene Oxide Sterilization Validation Procedure
Regular price $149.00Regular priceUnit price / per