Overview:
There is no universal standard for assigning risk to a medical device, and competing manufacturers of devices may quantify risk differently for similar identified hazards. One manufacturer may identify a hazard as a high enough risk to warrant triggering an alarm, and their competitor may decide that same hazard is not such a high risk and just note it as a "feature" for the label. We will together construct a simple example of a risk table using known standards, guidelines, regulations, and public data.
The FDA considers a device to consist of: 1. The physical device itself; 2. Packaging; 3. Labeling; 4. Instructions for use; and 5. Applicable quality systems regulations. The FDA considers a device adulterated if it is not in compliance with any of these areas and can consider the device as being illegally marketed in the USA.
Internal and external files and documents must be reviewed by manufacturers when taking corrective action/preventive action (CAPA) to reduce risk to an acceptable level. Most applicable are the device's complaint file, risk file, device history file, and medical device reporting file. All medical device manufacturers should regularly review these files and compare the information to what is public data on the FDA web site. It can be a big problem if deaths or severe injuries are reported on the FDA's site and the manufacturer has incomplete information on the event
Why should you Attend: Even if the device has predicates no two manufacturers assign risk in exactly the same way. You need to document your hazard identification and risk assignment and continuously update the risk table in order to make sure the medical device is safe, effective and complies with regulatory obligations.
There is what the regulations state, and then there is what happens out in the real world. Prepare a robust risk table as it pertains to your medical device.
Areas Covered in the Session:
FDA's Quality Systems Regulations, 21 CFR 820:
Complaints 21CFR820.198
CAPA 21CFR820.100
Nonconforming Product 21CFR820.90
Design Controls 21CFR820.30
Production and Process Changes 21CFR820.70(b)
Total Product Life Cycle data:
Recalls and warning letters
Form 483s
FOIA requests
Standards
Risk Management for Medical Devices ISO 14971
Usability Engineering for Medical Devices ISO 62366
Some ISO standards include hazards, such as for supralaryngeal airways and connectors:
ISO 11712
Construct a simple risk table:
Hazards
Probability
Severity
Occurrence
Threshold or levels of assigned risk:
Acceptable
Conditional
Unacceptable
There is no universal standard for assigning risk to a medical device, and competing manufacturers of devices may quantify risk differently for similar identified hazards. One manufacturer may identify a hazard as a high enough risk to warrant triggering an alarm, and their competitor may decide that same hazard is not such a high risk and just note it as a "feature" for the label. We will together construct a simple example of a risk table using known standards, guidelines, regulations, and public data.
The FDA considers a device to consist of: 1. The physical device itself; 2. Packaging; 3. Labeling; 4. Instructions for use; and 5. Applicable quality systems regulations. The FDA considers a device adulterated if it is not in compliance with any of these areas and can consider the device as being illegally marketed in the USA.
Internal and external files and documents must be reviewed by manufacturers when taking corrective action/preventive action (CAPA) to reduce risk to an acceptable level. Most applicable are the device's complaint file, risk file, device history file, and medical device reporting file. All medical device manufacturers should regularly review these files and compare the information to what is public data on the FDA web site. It can be a big problem if deaths or severe injuries are reported on the FDA's site and the manufacturer has incomplete information on the event
Why should you Attend: Even if the device has predicates no two manufacturers assign risk in exactly the same way. You need to document your hazard identification and risk assignment and continuously update the risk table in order to make sure the medical device is safe, effective and complies with regulatory obligations.
There is what the regulations state, and then there is what happens out in the real world. Prepare a robust risk table as it pertains to your medical device.
Areas Covered in the Session:
FDA's Quality Systems Regulations, 21 CFR 820:
Complaints 21CFR820.198
CAPA 21CFR820.100
Nonconforming Product 21CFR820.90
Design Controls 21CFR820.30
Production and Process Changes 21CFR820.70(b)
Total Product Life Cycle data:
Recalls and warning letters
Form 483s
FOIA requests
Standards
Risk Management for Medical Devices ISO 14971
Usability Engineering for Medical Devices ISO 62366
Some ISO standards include hazards, such as for supralaryngeal airways and connectors:
ISO 11712
Construct a simple risk table:
Hazards
Probability
Severity
Occurrence
Threshold or levels of assigned risk:
Acceptable
Conditional
Unacceptable
Speakers
Christina Bernstein,
Who Should Attend
- Quality Engineer
- Clinical Field Representative
- President
- Vice-President
- Controller
- Risk Manager
- Chief Financial Officer
- Corporate Counsel
