As clearly stated in Article 10 of the 2017/745 MDR, manufacturers must establish a quality management system that demonstrates evidence that their products and critical processes of the products are identified and kept under control. This will be subject to inspection by the Notified Body during the certification processes.
effective quality system; It should cover the manufacturers' processes defined in Article 10, the documentation created to realize these processes, and manage the structure, responsibilities and resources within the company.
The QMS features defined in MDR Article 10 largely overlap with the requirements of the ISO 13485 standard, enabling the Organization to dedicate itself to meeting customer and regulatory requirements by adopting the 'process approach' and improving system effectiveness by implementing the Plan, Do, Check, Act or Improve cycle. .
Establishing and maintaining a quality management that meets the requirements of the ISO 13485 standard enables products to adapt more quickly to MDR's requirements in the following processes;
Infigen Consultancy has 20 years of experience in designing Quality Management Systems for medical device organizations, and will be pleased to offer tailor-made solutions for your organization with its expert staff.
It should not be forgotten that; It is essential that you need an effective quality system that supports and develops your organization, not burdening it, and that is suitable for and control over the daily processes of your organization.
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