Hello everyone, I hope everything is going well.
Dr. Simon mentioned in the lecture that you during the design verification and validation phase, the engineer is supposed to kind of “make up a test.” I am completely sure that all these tests would vary depending on the biology, chemistry and physics of the medical device, but does the FDA suggest or demand specific tests? I am very curious to know how would you choose the correct tests for the project going on. Is there any outline suggested for this procedure?
Thank you
-Roberto P
From my experience with Validation and Verification, I have particularly worked on lab equipment or instruments used to make or inspect a particular medical device in a manufacturing settings. With respect to equipment/instruments the company may have a template on how establish or approach your validation/verification. With the design of a medical device the FDA has established recommendations, I attached a link with Design controls from the FDA that cover validation and verification. http://www.fda.gov/RegulatoryInformation/Guidances/ucm070627.htm
Chris
Most of the verification and validation tests are carried out by international standards such as ISO or ASTM. These standards specify the testing for strength, biological and chemical properties of the material used in product. For example, ISO 6872 specifies the requirements and the corresponding test methods for dental ceramic materials for fixed all-ceramic and metal-ceramic restorations and prostheses. Moreover, companies can also create their own testing to validate the process and design output.
For verification, it's important to note that tests aren't the only acceptable verification activities; a company can also utilize inspections and analyses for their requirements, which can sometimes be cheaper and/or less time-consuming than tests. Some examples of these alternate verifications include: "thermal analysis of an assembly to assure that internal or surface temperatures do not exceed specified limits" and "worst case analysis of an assembly to verify that components are derated properly and not subject to overstress during handling and use". Of course, depending on the product these other avenues of verification may not be substantive enough, but it's good to keep in mind other avenues.
http://www.fda.gov/downloads/MedicalDevices/.../ucm070642.pdf Page 39
During my experience, I have noticed that most companies have Validation Engineer that performs various tests to validate a machine which is also known as (IQ, OQ, & PQ). There are some specific guidelines set by the FDA that aide the Validation Engineer when carrying out the tests. Furthermore, there are different kinds of validations such as design validation, software validation, machine validation etc. that requires different method. Usually, validation engineer tries to takes the worst case possible to make sure the process is repeatable and documents the objective evidence. All in all, I agree with the above posts and the lecture notes on verification and validation.
There are typically pre-existing standards for the verification testing. International ISO standards exist to insure that proper function and safety are accomplished. Additionally, for medical devices, FDA regulations define verification and validation in design control training. Proper traceability and documentation must also exist to adequately record test results. Often times engineers can look to previous test plans that were carried out or contact vendors for testing procedures on theirs specific components.
-Romany
In my company, typically for testing our implants we follow an FDA guidance document that details the recommended tests for that type of device, and we submit this test data with our 510k submissions. However, sometimes we feel that additional tests are necessary which are not recommended or required by the FDA, or sometimes upon review of our 510k submission the FDA will ask for additional test data that was not mentioned in the guidance document. For our instrumentation used in conjunction with our implant system, however, there are no standardized tests and no guidance documents that we follow. This is strictly up to the engineers to define these tests to make sure the design of the instruments is robust.
In response to the experience seen in industry, I have similar input as hruship101 and srg36. Working for a global SMBG company, validation and verification (V&V) is understood to be our leading factor in producing products of high quality. Accuracy, durability, reliability, and consistency are very critical aspects in providing persons with Diabetes their blood glucose readings. Since the majority of our products are Class II medical devices, our V&V process follows a specific product-based FDA guidance. To determine the V&V activities that will be conducted for each of our products, whether new or updated, there must be transparent and consistent collaboration between the Quality, R&D, Operations, and Regulatory teams. The baseline is established from the requirements for CE mark (ISO standards), Health Canada, and FDA 510k submissions. These requirements mostly focus around the FDA guidance, since the U.S. is the most stringent. Additional reliability and environmental V&V tests are included, ensuring good practice and that quality expectations are being exceeded. Each company is unique in their own methods. This SMBG company created their own product guidelines, listing requirements at each stage or product development. For a better understanding of our V&V process: testing pilot run prototypes (could be multiple versions depending on the development of the product; usability, software, reliability, linearity, virucidal, aging, biocompatibility, sterility, etc.), testing installation, operation, and production assembly (IQ, OQ, and PQ with sterility), testing pre-production product samples (confirmation of the same tests done for prototypes, but now for regulatory submissions), packaging/labeling tests, then final tests in mass-production product samples. In trying to state the importance of V&V testing, this company has been performing V&V tests for blood glucose systems for over 30 years, and they are still continuously thinking of ways to modify or have additional tests to improve the quality of their product.
I agree with all of the posts above, however I would like to elaborate on the high level understanding of verification and validation testing, based off my experience at Stryker. I was able to see many of these "tests" done on the patient specific cut guides created for ankle replacement surgeries. The verification of the device included many tests to confirm the 3D printed pieces were manufactured accurately within the tolerances planned in ProE. Basically, to verify that the part was created properly to maintain high standards. The validation of the cut guides consisted heavily of surgeon feedback to confirm the goals of the device has been met. For example, feedback about the fit of the cut guides in the cadaver labs, the ease of use, and time saved during the procedure were all ranked on a numeric scale. There was no outlined procedure for all of the V&V tests needed to be done, however the engineers on my team had to follow similar tests done for other medical devices to make the process smoother.
So it really depends on the product. Most of the products functional testing are per ISO and ASTM standards, which are international standards that most of the international health authorities require. Sometimes there are extra standards to be followed besides the common ones in some regions/countries depending on their regulations, or they might just follow a different revision of the standard. For example if we are dealing with an insulin syringe, we should look at ISO 8537 and 9626 for the labeling and function testing of the syringe including the cannula tests. Biocompatibility and sterilization (for sterilized products) are also performed in accordance to ISO ISO10993 and 11137 respectively. Of course there are more standards to look at for specific products and requirements but there are some main standards that the product has to comply with. FDA also offers a list of standards to comply with depending on the product listed as "Recognized Consensus Standards". Besides those standards, there are some internal requirements, some of them can be based on market requirements or compliance with other products, to ensure the safety and effectiveness of the product and to avoid any complaints or recalls. The team has to also come up with a risk management file, where they basically list all the risks associated with the use of the product, and therefore they would be able to determine what tests would be needed to ensure that those risks are mitigated. After having all this information, the team would have a list of technical design inputs that would define the product's design traceability matrix and design verification plan.
Hello everyone, I hope everything is going well.
Dr. Simon mentioned in the lecture that you during the design verification and validation phase, the engineer is supposed to kind of “make up a test.” I am completely sure that all these tests would vary depending on the biology, chemistry and physics of the medical device, but does the FDA suggest or demand specific tests? I am very curious to know how would you choose the correct tests for the project going on. Is there any outline suggested for this procedure?
Thank you
-Roberto P
Project planning is one of the pivotal elements in the project management process.How each individual team interprets the goals to be achieved, is a direct representation of the level of clarity incorporated in the project plan. Especially when it comes to a test project, inaccurate project planning can have a serious implication on the test execution of the system under test and on the overall quality of the product as a whole.
So it really depends on the product. Most of the products functional testing are per ISO and ASTM standards, which are international standards that most of the international health authorities require. Sometimes there are extra standards to be followed besides the common ones in some regions/countries depending on their regulations, or they might just follow a different revision of the standard. For example if we are dealing with an insulin syringe, we should look at ISO 8537 and 9626 for the labeling and function testing of the syringe including the cannula tests. Biocompatibility and sterilization (for sterilized products) are also performed in accordance to ISO ISO10993 and 11137 respectively. Of course there are more standards to look at for specific products and requirements but there are some main standards that the product has to comply with. FDA also offers a list of standards to comply with depending on the product listed as "Recognized Consensus Standards". Besides those standards, there are some internal requirements, some of them can be based on market requirements or compliance with other products, to ensure the safety and effectiveness of the product and to avoid any complaints or recalls. The team has to also come up with a risk management file, where they basically list all the risks associated with the use of the product, and therefore they would be able to determine what tests would be needed to ensure that those risks are mitigated. After having all this information, the team would have a list of technical design inputs that would define the product's design traceability matrix and design verification plan.
This sums a large amount of the verification activities completed for the project. There are also other areas of consideration where regulatory bodies can accept or reject the tests based upon their level of scrutiny in their country such as in China where standards are close to, but not always the same as the ASTM/ISO standards. Some tests are noncompendial tests as well where a group would need to provide evidence that the method is validated to assess performance (not to be confused with validation of the product).
For product validation, the tests can be created based upon user performance and the design inputs/specifications creating during the planning phase. There can be validation tests based upon product look and feel that can be extremely subjective to the user, but are important to prove that the instrument works as intended and does not have many chances of misuse by the user.
While working as an intern for a medical device manufacturing company, I was able to assist project engineers in both the development of methods to assemble components and verification tests. As for verification tests on components being assembled, many of the tests were designed and constructed by the project engineers. In fact, many tests even required the designing and development of custom fixtures and tools. As for guidelines, one verification test that I helped develop work instructions for required the use of a specific material during testing. This verification test was applied to needles manufactured by the company to assess the force required to puncture the specific material. Overall, while there are guidelines depending on the product, many verification tests have to be designed and tailored according to the required outputs specified in the DSD.
