ISO 13485 is the leading global standard in medical device quality management. The fact that it is comprehensive is a key reason it stands above all other attempts to synthesize expertise on this complex subject. It offers crucial guidance through each phase of product design, management, distribution, and installation calibrated to achieve success in a regulation-driven global market.
Naturally, ISO 13485 quality management begins with product design and development.
Sound Medical Device Design is the Foundation of Everything that Follows
From a quality and manufacturing standpoint, product design and development can be called the bedrock of medical device innovation. This step takes the concept of a product and begins to build the framework of technology and subject matter leadership necessary to make it a reality.
All subsequent steps are deeply influenced by the decisions made during design and development. A failure of imagination, science, or market understanding at this point will hinder a product from reaching full potential. In the worst case scenario, it may even lead to legal liability in the future.
In short, a product design must be sound, robust, and achievable under given market constraints.
Design is also the step where the insights gained in the R&D process begin their evolution into practical applications. The importance of this cannot be understated: Between 2012 and 2013, the top R&D investors in the med tech space increased their research investment by more than 50X.
During a design and development process informed by ISO 13485, stakeholders define:
- The functional, performance, and safety requirements of the device according to its use;
- The statutory and regulatory requirements that may pertain to the new medical device;
- Any relevant information from previous product designs executed by the organization;
- Additional requirements that can be considered essential for design and development;
- Outputs of risk management assessments appropriate to the product and its market.
Understanding ISO 13485 Recommendations in Design and Development
ISO 13485 does not merely define steps and provide benchmarks or trigger events for particular quality actions. It is intended to serve as a complete quality management framework for medical devices and their regulatory compliance. Thus, it points the way to development of systems and dependencies that will generate the necessary compliance outputs in a robust and reliable manner.
This results in testing, verification, and documentation that could otherwise be easily overlooked.
For example, ISO 13485 advocates for robust, multi-level planning across the design process. It is not enough to set objectives for the product and processes for executing them: Stakeholders must also define the verification, validation, monitoring, inspection, and test activities specific to the product so that product acceptance benchmarks can be understood early in the process.
In addition to clear review, verification, and validation steps, ISO 13485 supports change control mechanisms within design and development. This helps to accelerate the design process while minimizing scope creep and reducing the likelihood of rework.
Combined with its steps for communicating with key stakeholders, the design and development process outlined in ISO 13485 clarifies objectives, authorities, and documentation in a way that protects customer needs and company interests. The standard refers repeatedly to the need to define and manage customer requirements, particularly in the early stages.
Tap Your Enterprise’s Full Potential with ISO 13485-Compliant Design and Development
An efficient design and development process gives you the structure to achieve your technical and commercial goals. Following ISO 13485 from the start can help you deliver your project on time and on budget. It also strengthens your outlook for FDA and global regulatory compliance.
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