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ISO 13485:2016 FOR RS.6000/-
ISO 13485: 2016 specifies the requirements for a quality management system when an organization has to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and Carry out related services. Most regulators in the global medical device market require manufacturers to implement quality management systems (QMS) as part of their product registration efforts. In most countries, ISO 13485 certification is the preferred or required method to meet QMS requirements.
ISO 13485 advantagesHere's what medical device manufacturers can expect from ISO 13485:2016 certification:
- » Access to markets including Canada and Europe that require certification or require certification.
- » Reduce operating costs by highlighting process gaps and improving efficiency
- » Increase customer satisfaction by consistently delivering quality products and handling complaints systematically
- » Commitment to quality thanks to an internationally recognized standard
- » Adds transparency of complaint, monitoring or product recall
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