ISO 13485


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ISO 13485 provides a framework for building organizational resilience with the capability of an effective response that safeguards the interests of its key stakeholders, reputation, brand and value-creating activities.

  • Holistic Management Process: Identifies potential threats to an organization and the impacts to business operations those threats.

  • Customers first: Putting your customers first, making sure you consistently meet their needs and exceed their expectations. This can lead to repeat custom, new clients and increased business for your organization.

  • Continual Improvement based on regulatory requirements: MD-QMS provides framework for continual improvement which are based on compliance obligations of regulatory requirements such as EU-MDR, MDR/FDA compliance along with applicability.

  • Give Assurances which clients can rely upon: An effective MD-QMS prepares organisation better operate during any disruption, loss, emergency or crisis.

  • Work - Efficient way: Work in a more efficient way as all your processes will be aligned and understood by everyone in the business or organization, which increases productivity and efficiency, bringing internal costs down.

  • Competitive Advantage: Address, mitigation risk and identify, capture opportunities for achieving objectives.

  • Improved business performance and organizational resilience: Better understanding of the business through analysis of critical issues and areas of vulnerability.