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ISO 13485

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ISO 13485 Certification Service in New York

ISO 13485 is a complex standard that outlines requirements for a quality management system (QMS) specifically tailored to the medical device manufactures, traders and service industries. Hiring regulatory consultants like I3CGlobal ensures that the company receives guidance from professionals who understand the system and regulatory standards and how it applies to their specific type of business.


Consultants can help ensure that the organisations quality management system fully complies with the requirements of ISO 13485. They can identify areas where the company may be falling short and provide guidance on how to address any non-conformities.

ISO 13485 Certification - Role of Consultants

I3CGLOBAL Consultants play a crucial role during medical device product certification and ISO 13485 certification. Few details below.


  • Consultants develop a customised ISO 13485 implementation plan tailored to the organisation’s needs and resources. This plan outlines the steps, timelines, and resources required to establish an effective QMS that aligns with ISO 13485 standard requirements
  • Consultants can provide training and support to employees throughout ISO 13485 Implementation and certification process
  • ISO 13485 Consultants ensuring that every process owner understands their roles and responsibilities regarding quality management and compliance with ISO 13485.
  • Consultants can help identify potential risks to product quality and patient safety and develop strategies to mitigate those risks effectively.
  • Consultants support in process validations
  • Consultants guide on facility / Layout
  • Consultants assist in conducting internal audits to assess the effectiveness of the QMS and identify areas for improvement.
  • ISO 13485 Consultants provide guidance on conducting audits, analysing findings, and implementing corrective and preventive actions (CAPAs) to address non-conformities.
  • Consultants support the organization during the third party certification audit. They facilitate communication with auditors, and address any findings or observations raised during the onsite audit process.


We, ISO 13485 consultants provide valuable expertise in the ISO 13485 Certification process in New York, New Rochelle, Hoboken, Elizabeth and New Jersey.

ISO 13485 Certification with I3CGlobal Team

The following are the major benefits in outsourcing  ISO 13485 maintenence


  • Consultants bring specialised knowledge and experience in implementing ISO 13485, ensuring efficient compliance
  • Consultants ensure full adherence to ISO 13485 requirements, reducing the risk of non-conformities.
  • They provide training and support to employees, fostering a culture of quality and continuous improvement
  • Outsourcing ISO 13485 implementation maintenance can lead to greater efficiency and time savings, as external partners often have streamlined processes and dedicated resources.
  • Outsourcing provides access to talent and specialised skills that may not be available internally. This can lead to higher quality outcomes and innovation.

Frequently Asked Questions

ISO 13485 Implementation and Certification Timeline?

Generally Implementation takes approximately 3-4 months and Certification 2-3 months.

What kind of organisation can apply for ISO 13485 Certification?

  • Medical Device manufactures
  • Medical Device traders
  • Medical Device service organisations
  • Medical Device designers
  • Medical Device Exporters
  • Medical Device Manufactures planning for CE Certification
  • Medical Device organization planning to participate in international Tenders
  • Medical Device manufactures expecting customer audits
  • Medical Device Component manufactures
  • In-vitro diagnostic device manufactures
  • Medical Device Sterilization facilities


Current Standard for ISO 13485?

ISO 13485:2016

EN ISO 13485:2016

BS/EN ISO 13485:2016