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Design and development validation and verification according to ISO 13485

Producing any part of a product includes validation and verification in its design and development. ISO 13485 requirements are a great way to start, since it’s targeted specifically to medical device manufacturing.

According to the American Society for Quality, the definition of validation in a quality environment is the act of confirming that a product or service meets the need for which it was created. The definition of verification is the act of determining whether a product or service can meet a specific requirement. One of the most critical and fundamental components of product creation includes ensuring the product will perform as intended.

For more about process validation in ISO 13485 read the article Using ISO 13485 to manage process validation in the medical device manufacturing industry.

What does product design mean within ISO 13485?

According to ISO 13485, product design includes both validation and verification of the medical device. A manufacturer may want to pause and consider answering some of the following questions, in order to establish design controls required for the medical device industry:

  1. What is my device going to do?
  2. What is needed to make this device work?
  3. How can we make sure this device will provide the right service and give the expected result with each use?
  4. How can we show proof of each question we are asking?

What does product development mean within ISO 13485?

Once the questions surrounding the design concept are answered, a company must venture into the actual development of a medical device. As a part of the design and development plan, the development phase takes a product from a concept or an idea and brings it into the realm of reality. As a medical device manufacturer making the leap from concept to reality, seek to answer the following question: How does one ensure the intended objective remains the same?

To learn more, read the article How to manage design and development of medical devices according to ISO 13485:2016.

ISO 13485: Design and development validation and verification

Device manufacturing according to ISO 13485

For medical device manufacturing, ISO 13485 is the quality management system that provides the blueprint for ensuring the leap from design to development is conducted in a structured manner. This will leave no stone unturned, no process unverified and no procedure undocumented. The standard requires both validation and verification of the design phase and the development phase when manufacturing a medical device. ISO 13485 requires the following steps be taken to accomplish successful device manufacturing:

Determination of Input Requirements. What does your organization need in order to see the medical device vision become a reality? Input requirements can be identified by considering the answer to these questions:

  • What is needed to make this device work? How do we move from an idea to a physical product?
  • What questions will this device answer? What medical problem will this device solve?
  • How can we make sure this device will give the right service or answer with each and every use?
  • And lastly, how can I show proof of each of these answered questions?

Evaluation of Input Requirements. Can you prove what you think will work, actually works in reality? Start with writing down your idea, document your experiments, your trials, and every error! Capture how you finally reached your goal. Were there moments in the experiment that made you decide to take one path or another? Those are called decision points, and you should be sure to document each of these.

  • As validation and verification begins, a company must provide proof of each question answered. The goal is to prepare and organize documents to capture each defined input requirement.
  • Input requirements are then reviewed to determine the decision points which led to the initiation phase of device manufacturing. This is also known as the first step of the product life cycle and is justification in decision making or evidence-based research.

Planning and Documented Efforts in Design Development. Can you give reasoning for why you chose to use supplier A over supplier B, or one product design over another? Can you confirm that your risks have been evaluated and minimized? If so, document that to show all the steps taken in the process. Can you provide evidence of mathematical calculations used to evaluate the processes used in product design, if applicable? Are all results and final decisions documented?

Medical Device Field Evaluation. How does your medical device work outside of the space it was created in? Has it been tried on people that it may actually help? Has the product lived up to your expectations? Are there any laws that your device must comply with? Are there any laws that control the manufacturing practices, and were those laws followed?

Download this free checklist to see which mandatory documentation is required by ISO 13485.

Use the ISO 13485 standard to ensure recognition and regulatory compliance

Device validation and verification is critical to successful manufacturing and compliance with ISO 13485. Ensuring proper records are kept, compliance with established QMS and local regulatory requirements also confirm consistency in medical device designs throughout the world. To learn about consequences of non-compliance read the article What are the consequences of noncompliance with ISO 13485 for manufacturers of medical devices?

Consistency and stringency in medical device manufacturing involve fully exploring and documenting each phase of product design, development, and release to the public market. Such a level of quality involvement is likely to reduce the number of faulty devices within the market and establish a uniform plan which can assist companies in properly managing each phase of a product’s design and final development.

Hopefully, with the steps outlined above, there is a fresh perspective on how to shift your product from an idea to an actual concept.

Taking these steps to achieve medical device manufacturing in accordance with ISO 13485 will ensure your product is accepted as a device manufactured in a controlled manner. Just imagine, your operations will be categorized within a community of global device manufacturers.

Learn more about ISO 13485 design and development requirements with this Clause-by-clause explanation of ISO 13485:2016.

Advisera Chany Runnels
Chany Runnels
Chany Runnels has a BS in Biology and an MBA with a concentration in Organizational Management. She has consulted in healthcare, industry, and government, providing roadmaps for the implementation of Quality Management Systems. She has successfully led laboratories in the manufacturing verification of medical devices, which were distributed domestically and internationally. These devices were compliant with FDA cGMP and modeled in accordance with ISO 13485. Previously serving as a Forensic Biology SME, she has been qualified as an auditor for ISO 17025/Forensic Testing Agencies and FBI’s QAS.