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ISO 13485

Overview

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Medical device QMS. A medical device is a product, such as an instrument, machine, implant or in vitro reagent that is intended for use in the diagnosis, prevention and treatment of diseases, rehabilitation of illness and disease or other medical conditions. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

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ISO 13485 clients

Alpha Therapeutics Pvt. Ltd
Phoenix Dental Equipments pvt. Ltd
Universal Orthosystems
Roselabs Biosciences Ltd.
Alpha Medicare and Devices Ltd.
Medicare Hygiene Limited

Training

Our team of ISO 13485 Consultants offers a customized training program on ISO 13485:2015 for

ISO 13485

Implementation and documentation requirements

ISO 13485

Internal Auditor training

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Frequently Asked questions

All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations.

The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain. Furthermore it now includes stakeholder’s role, improvement in feedback processes and traceability.

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Empower your business with 4C

  • Qualified, Experienced and Competent team of ISO 13485 consultants working across India
  • Team 4C has certified ISO 13485 consultants and auditors for Consulting Services having 15+ years of experience
  • 1000+ Hours of training and 3000+ Hours Consulting provided so far
  • Worked with more than 50 International & National Certification Bodies
  • 25+ implementation in 09 different industries worldwide