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Systemic requirements
4.1 Organizational requirements
Establish a file for each medical device type or each family of medical devices.
Include or reference documents showing that you comply with regulations.
Include or reference documents showing that you comply with ISO 13485.
Maintain a file for each medical device type or each family of medical devices.
Include documents for each medical device type or family of medical devices.
Include a description of each medical device type or medical device family.
Include procedures for medical device types or medical device families.
Include specifications or procedures for medical device types or families.
Include records for medical device types or medical device families.
5. Management requirements
5.1 Commitment requirements.
6. Resource requirements
6.1 Allocation requirements.
Identify personnel and examine work that could affect product quality.
Establish a process to manage the competence of medical device workers.
Use your process to manage the competence of your medical device workers.
Select suitable methods for evaluating your training and awareness activities.
Maintain records that document the competence of medical device workers.
Plan how you're going to control products that are or may be contaminated.
Plan how you're going to control the contamination of sterile medical devices.
7. Realization requirements
Maintain a design and development file for each family of medical devices.
Include or reference records that document compliance and changes.
Identify products that must be clean when used but are supplied non-sterile.
Document and maintain cleanliness or contamination control requirements
for products that must be clean when used but are supplied non-sterile.
Identify process agents that must be removed from product during manufacture.
Document and maintain cleanliness or contamination control requirements
for process agents that must be removed from products during manufacture.
8. Remedial requirements
8.1 Planning requirements
Establish a process to manage and control the risksassociated with your organizations
medical devices.
Maintain your risk management process for every medical device throughout its entire lifecycle.
Make sure that top management demonstrates a commitment to medical device risk
management.
Make sure that top management reviews the suitability of your risk management process at
planned intervals.
Make sure that records are kept that document the qualifications of your risk management
personnel.
Describe how verification activities will be done for each medical device.
Use your risk management file to record risk analysis results for each identified
hazard.
Use your risk management file to record risk evaluation results for each identified
hazard.
Use your risk management file to record risk control measures and results for each
identified hazard.
Use your risk management file to record residual risk evaluation results for each
identified hazard.
Make sure that you will be able to assemble all referenced information in a timely
fashion.
Use your risk management file to document your analytical activities and results.
Identify the hazards that could possibly affect the safety of your medical device.
Document the known and foreseeable hazards that could affect the safety of your medical
device.
Use your risk management file to maintain the documents that identify and describe the
hazards that could affect the safety of your medical device.
Use your risk management file to record the results of your risk estimation activities.
Use your risk management file to record the process or system you use to estimate
risk.
Study each hazardous situation and then use your risk acceptability
criteria to decide if risk reduction is required in each and every case.
Use your risk management file to record the results of your risk evaluation activities.
Use your risk management file to record the risk control measures you have chosen to
implement.
Check whether your organization complies with Part 6.2 by inspecting your risk
management file.
Use your risk management file to record the results of your risk control verification
activities.
Check whether your organization complies with Part 6.3 by inspecting your risk
management file.
Evaluate your residual risk (the risk left over after youve implemented your risk control
measures).
Use your risk acceptability criteria to evaluate whether or not your residual risk is
acceptable.
Use your risk management file to record the results of your risk benefit analysis.
Review your risk control measures to see if they generate unintended consequences.
Manage and control all new or modified risks whenever your risk profile changes.
Use your risk management file to record the results of your risk control review.
Make sure that all hazards and all identified hazardous situations have been considered.
Check whether your organization complies with Part 7 by inspecting your risk management
file and the medical devices accompanying documents.
Make sure that your risk management plan indicates who is responsible for reviews.
Carry out a risk management review before you release your medical device for commercial
distribution.
Prepare a risk management report before you release your medical device for commercial
distribution.
Use your report to record the results of your risk management review.
Check whether your organization complies with Part 8 by inspecting your risk management
file.
Establish a system to monitor medical devices during production and postproduction phases.