The US Food and Drug Administration (FDA) and the international regulatory standards continue to evolve and become more stringent. Medical devices are also becoming smaller and more complex in design and their functionality. This makes the process of design verification even more important, not only to comply with regulations but also to design the highest-quality part and production process.
The result is better repeatability, fewer mistakes, less rework and redesign, faster time to market, improved competitiveness, and lower production costs.
Design verification is not only needed for pure medical devices but also for combination products where for example a pharmaceutical product includes device consistent part.
According to the FDA, guidance verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
Types of verification activities
Verification activities are conducted at all stages and levels of device design. Verification is usually done by tests, inspections and in some cases analysis. Any approach that establishes conformance with a design input requirement is an acceptable means of verifying the design with respect to that requirement. In many cases, a variety of approaches are possible.
In the following, a few examples of verification methods and activities are listed:
- Functional testing (such as specified gliding forces of pre-filled syringes)
- Biocompatibility testing of materials
- Bioburden testing of products to be sterilised
- Dimensional testing of components
- Fault tree analysis of a process or design
- Failure modes and effects analysis
- Package integrity tests
Documentation of verification
The most important document to plan verification activities is the design verification plan. The perfect time to construct a design verification plan is just when defining the design input requirements. This also helps to reflect how to verify these requirements in an early stage during the process of defining the design inputs.
One document to ensure that all of your design input has been verified is the traceability matrix, which is very useful for tracing the design input requirements, user requirements and testing documentation; here great software solutions are available such as tachysCP.
In the most common form of the traceability matrix, the input requirements are enumerated in a table, and references are provided to each section in the output documents which address or satisfy each input requirement.
The results of all design verification activities are typically concluded in a verification summary report.
Why design verification testing?
There are FDA requirements (§ 820.30(f)):
- Each manufacturer shall establish and maintain procedures for verifying the device design.
- Design verification shall confirm that the design output meets the design input requirements.
- The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the design history file.
In addition, design verification failures are costly and may result in rejection of submissions, warning letters, recalls, loss of market share, or patient harm. Design verification is one of the most commonly cited sections in recent warning letters issued by the FDA, which include findings related to specific sections of the Design Control regulation (21 CFR 820.30).
What to do now?
You are currently in the process of defining your design inputs or you are about to start implementing your test protocols and need a partner to perform pre-testing or testing? You should define your requirements smooth or check the traceability and completeness of your documentation.
anteris medical and anteris systems are able to support you in all areas of this challenging project. They offer effective project management, tying together your internal organisation, development partners, suppliers and notified bodies.
The companies are life sciences and engineering majors with dozens of years of experience in CE marking, 510(k) submissions, and quality systems regulations in all major markets.