An example of a combination product: Bone morphogenetic proteins (BMPs are a class of proteins) that induce bone formation. New technology in orthopedic repair combines BMPs with a carrier matrix to create a combination product that, when implanted in a bony defect, initiates bone formation (osteoinduction) and provides local containment and cell…[Read more]

As we learned from Simulation 2, ,the IQ, OQ, and PQ required for proper inspection. During the validation process all the data need to be analyzed and documented. You should analyze each input and fully verify the results. Validation is the process of making sure that you have objective evidence that user needs and intended uses are met. It is…[Read more]

Validation is the process of making sure that you have objective evidence that user needs and intended uses are met. It is usually done by tests, inspections, and analysis. However, the target of the validation is to make sure the user needs are met in a medical device in both ISO,FDA. A successful validation process would clearly define inputs…[Read more]

Actually, the FDA reviews the validation of the manufacturing processes. According to 21 CFR 820.75, which states that “where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated”. The validation for manufacturing processes should be documented according to the respective procedures…[Read more]

An example for managing the risk for a medical device:
There is a medical device called “PEMF: Pulsed ElectroMagnetic Field”, this device is being used for bone simulation (bone healing).
In terms of risk management, for example, risk of Toxicity, this could happen because PEMF stimulates cell metabolism functions. These functions include…[Read more]

As we learned, in the planning phase its important to do:
1- Scope Statement:
the statement thoroughly describes the project, and objectives of the project . The statement also describes the project’s context. When everyone agrees with the statement, the project can proceed.
2- Schedule/WBS/Gantt chart
3- Quality Management Plan
Describes how the…[Read more]

Regarding to risk management, as we learned in Week 5, in project management plan you need to measure the risk, Assess, Evaluate, and finally how to manage the risk. By the time a risk actually occurs on any project, it’s too late to do anything about it. That’s why you need to plan for risks from the beginning and keep coming back to do more pla…[Read more]

As Dr.Simon mentioned, if you failed to plan so you planning to fail. Planning phase is very important in any Medical Device project. Its important to identify critical interfaces in your project, resources you need, milestones you need to achieve and when you’re going to have design reviews. Its important to have a plan for each task in the p…[Read more]

Adding to the discussion, another pitfall in Gantt chart that if you have poorly defined CAPA time-frames.
CAPA which means establishing a corrective and preventive action system, which is required in (QSR) a quality system regulation for medical device for marketing products in the united states.
Solution: So, you must clearly define how long…[Read more]

I think re-validation is required or not depends on the product. So, you need to ask some questions about your medical device, is it something like class I devices, like tongue depressor for example, or it is a class III medical device ?. Validation process cost a lot of money sometimes. However, re-validation might be required, depends on the…[Read more]

Hi srg36, I think implantable orthopedic medical devices is the most highly regulated medical devices in the market. As we learned form the validation process lecture, Validation is to ensure that the medical device meets the user requirements and the intended use, so, for example, validation for a total hip joint replacement requires mechanical…[Read more]

An engineering change order (ECO) is a documentation packet that outlines the proposed change, lists the product parts that would be affected. ECOs are used to make modifications to components, assemblies, associated documentation and other types of product information. A good ECO contains the full description, analysis, cost and impact of a…[Read more]

Dr.Simon mentioned (in Week 3) about DHF, Design History File is required by law in 21CRF820.3(e) – “a compilation of records which describes the design history of a device”. Also, the DHF should contain some basic documents:
PDF, DDP, DID
– Business plan, market research
– Risk Analysis
– Research protocols: clinical and pre-clin
– Regulatory pa…[Read more]

Its very important on the validation process to make sure that the output equal to the user needs!. Before your company start marketing for a medical device, a successful validation should be submitted to the FDA according to FDA 21 CFR part 820. For a successful validation you need to answer some question like:
– Does the device work for the…[Read more]

Adding to the discussion, from my academic experience, for the documentation for any test done for a medical device,in general the risk management file which is done by QA department. For example, a medical electrical device evaluated according to standard IEC60601-1.
– Instructions for use, labeling and marking , including information essential…[Read more]

The Standard Operating Procedures (SOP) as SOPs are often used to demonstrate compliance with the regulation or operational practices and to document how tasks must be completed at any organization. I think SOPs is not required in the research role but its better to be created during the research phase. SOPs help you to evaluate more than what…[Read more]