ISO 13485 Certification | ISO 13845 Medical Devices – IAS

ISO 13485 Certification

Producing any part of a product includes validation and verification in its design and development. ISO 13485 Certification 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 the roles and responsibilities of ISO 13485 according to QMS

What does product design mean within ISO 13485 Certification?

According to ISO 13485 Certification, 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:

· What is my device going to do

· What is needed to make this device work?

· How can we make sure this device will provide the right service and give the expected result with each use?

· How can we show proof of each question we are asking?

What does product development mean withinISO 13485 Certification?

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.

Device manufacturing accordingto ISO 13485 Certification

For medical device manufacturing, ISO 13485 Certification 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 Certification 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

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