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ISO 13485:2016 - Medical Device Certification

A successful implementation will demonstrate a company’s ability to supply Medical Devices and related services to customers that comply with regulatory requirements ISO 13485 is not just products focused, but it focuses instead on the processes, used to develop Medical Devices.

Keep in mind that you also need to comply with all relevant product and service-oriented technical standards and regulations in this area of expertise. Although ISO 13485 is based on ISO 9001 Quality Management Standard and uses the same numbering system.

ISO 13485 doesn’t include the ISO 9001 requirements related to continual improvement and customer satisfaction ISO 13485 also focuses more on how procedures regulate and control activity and process performance.

Who can be get ISO 13485?

ISO 13485 applies to organizations of all types and sizes, except where expressly stated otherwise. ISO 13485 contains requirements that are required for any organization in the medical device and pharmaceutical supply chain, including design, production, installation, storage, development, and service.

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Testing Kits

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Medical Furniture

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Medical Equipment

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IVD Instruments

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Surgical Instruments

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Dental Implants

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Ortho Implants

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Disposable Syringes Needles

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Frequently Asked Question - FAQs

ISO Certification is a seal of approval from a  internationally recognised ISO management systems. The certification can be used to tender for business as a proof of a company’s credibility but also to install confidence in the potential client that you will keep your promises.

ISO certification is a must-have for any organization. It is a mark of quality and credibility for any company. There are different kinds of ISO 9001 certification based on the kind of business a company is into. No matter how big or small a company is, an ISO certification is always an asset for the organization.

Any certification body can only be stated as leading when they meet below requirement:
  1. Have 100% success rate on project completion.
  2. Have competent auditors within the organization.
  3. Have auditors on every industry sector.
  4. Audit techniques are on industry best practices.

Why an ISO is important for a company? ISO or the International Standards Organization is an independent body which provides standards of the organization.

ISO Certification costs depend on the size of an organization and the level to which the company is already run with regards to processes and procedures. If you decide to implement more than one standard at the same time, there are some preferential fees available. We are a fixed fee organization, which means once we have met you to discuss your requirements and sent you a formal quotation, this fee is then set. We will not charge you any extra.

Shamkris Group, is an Independent Assessment and Certification Body offering value added services Worldwide. Shamkris Group is amongst Best Certification Bodies of the World. More than 8,000 clients has reposed confidence in Shamkris Global as their Certifying Body to different certifications.

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