Services

NYQC provides varieties of services including Internal Quality Audits, Training,
Supplier Audits and Market Access and Device registration

ISO 9001:2015​

Is a Quality Management Standard which stipulates requirements for Quality Management Systems. The standard helps businesses and companies to improve efficiency and enhance customer satisfaction and services. Also, the standard focuses on continual improvement

  • Suitable for all sizes of organizations : Small, large
  • Suitable for all types of organizations : Service and Manufacturing
  • Suitable for all sectors of organizations : Government and Private sector
  • Based on Quality Management Principles

    • MDSAP TRAINING​

    The MDSAP was implemented-based on requirements that are defined in the IMDRF MDSAP Model; Five participating countries – Australia, Brazil, Canada , Japan and the USA.

    Regulatory authorities:
    1. TGA
    2. ANVISA
    3. Health Canada
    4. MHLW/PMDA
    5. FDA

    ISO 13485:2016​

    ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally recognized standard which sets out the requirements for a quality management system specific to the medical devices industry.

    The Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services which consistently meet applicable regulatory requirements and customer requirements.

  • Organizations can be involved in one or more stages of the life-cycle of medical devices, including design and development, production, installation, servicing, storage and distribution of a medical device and design and development or provision of associated activities (e.g. technical support)
  • Can be use by suppliers or external parties who provide product, including quality management system-related services to such organizations. Ex. Sterilization companies

    • REGULATORY AFFAIRS

    • Regulatory strategy development
    • Agency Interactions
    • Marketing approvals
    • Licensing renewals and submissions

    Our Expertise

    01. Implementation of ISO 9001:2015

    • Service and Manufacturing Industry
    • Gap Analysis audit
    • Supplier audits
    • Training – Onsite and Remote training

    02. Implementation of ISO 13485:2016

    • Gap Analysis audits
    • Supplier Audits
    • Internal Quality Audits
    • Risk Management

    03. Implementation of ISO 17025

    • Training
    • Gap Analysis
    • Supplier Audits
    • Internal Quality Audits

    04. MDSAP

    • Training
    • Gap Analysis
    • Internal Quality Audits

    05. EU MDR

    • Gap Analysis
    • Training
    • Internal Audits

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    Address

    Ottawa, Ontario, Canada

    Call Us

    +1 613 804-8674

    Email Us

    info@nyqc.ca

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    Nazeer Yakoob