Design and development validation and verification according to 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:
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
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
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
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
Click hear for
free checklist to see which mandatory documentation
is required by ISO 13485 Certification.
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 Certification. Ensuring proper records are kept, compliance with
established QMS and local regulatory requirements also confirm consistency in
medical device designs throughout the world.
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 Certification
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.
For more information about ISO 13485 Certification Body and
the role, we can play in your efforts to achieve certification to it, feel free
to contact
us. To get started with the
certification process, you can also request a quote.
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