ISO 13485 is the blueprint for quality management in medical devices. Design and development being very critical components of a medical device; ISO 13485 design and development is considered a very important section relating to this aspect of a medical device. Being the extant standard; the ISO 13485 standard has superseded a number of previous standards.
How important is ISO 13485 certification?
It is important for organizations to become ISO 13485 certified, because although this certification is not an end in itself in that it does not mean that the requirements of 9001 are being fulfilled or that the organization is automatically certified as having the ability to meet the standards set in any country; it means that the organization’s management system is being aligned to the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements globally.
What does ISO 13485 design and development entail?
ISO 13485 design and development is all about ensuring medical devices’ compliance with prescribed standards of global regulators.
Risk management is central to ISO 13485 design and development
Risk management is at the core of the quality management system, and has to be built into a product at the design and development stage. Built into the design and development stage; it has to permeate the product throughout its life cycle. Many organizations do not realize this, with the result that they end up messing up their certification. They think that risk management is good or necessary only at the design and development stage, which is actually not so.
Ensuring conformity without design and development controls
Another important element of ISO 13485 design and development is that of conformity. The way in which conformity is related to ISO 13485 design and development is that conformity with ISO 13485 has to be demonstrated when the product is free from design and development controls. When the product shows conformity even sans design and development controls; it is a sure means of ensuring that it meets ISO 13485 design and development standards.
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