MEDICAL DEVICE - QUALITY MANAGEMENT
We conduct Training, Implementation, consultancy, gap analysis, first & second party audits
Take ISO 13485 Internal Auditor or Awareness Training from us
IRCA-LA for ISO 13485 - in-house or as scheduled
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.