ISO certification india and ISO consultants india for iso 9001 ISO 14001 ISO 22000 haccp ISO 17025 NABL 27001 2000 13485 implementation in Mumbai, Nashik, Pune, India.

ISO 13485

ISO 13485:2003 is a quality system standard designed specifically for medical device companies.

ISO 13485 Mumbai- Medical devices -- Quality management systems -- Requirements for regulatory purposes specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The ISO 13485 standard supplements ISO 9001 and has many of the same requirements including additional requirements for process control, design control, retention of records, accountability, traceability and more.

Benefits :-

  • Increased efficiency
  • Cost savings
  • More effective risk management and quality assurance
  • An improved ability to respond to customer requirements are just a few of the potential results that certification to the standard can bring.
  • Certification to ISO 13485 satisfies a significant portion of the EU Directive requirements for marketing medical devices in Europe.

Who is it applicable for?

  • Companies who design, manufacture, distribute, install and service medical devices for the European and World markets.
  • Companies who manufacture OEM products which are sold under other company names.
  • Companies who design and/or manufacture medical device components or raw materials for the medical device market.
  • Companies selling, installing or servicing medical devices.
  • Consultants providing design services to the medical device market.
  • Companies providing services to the medical device market such as sterilisation, cleaning, testing, etc

How can ISO - Mumbai help you to get ISO 13485 Certification?

ISO - Mumbai specializes in the entire range of ISO management system certification standards. We have been able to establish our self among the well renowned names in the industry with the help of our excellent ISO Consulting Services. We have clients in more than 30 countries for various certifications like ISO 9001, ISO 14001, OHSAS 18001, HACCP ISO 22000 and ISO 27001. We have proven our mettle in providing the authentic ISO 13485 Certification Services to our clients spreading worldwide. ISO 13485 Medical Devices management system implementations with the consultants and experts of ISO - Mumbai not only assure 100% successful ISO 13485 certification but also improve process performance and business operations.

Consultants of ISO - Mumbai partner your company in your quality management initiative through ISO 13485 certification to get your company ISO 13485 certified quickly with ease of implementation and in the most cost effective manner. We make sure that ISO 13485 standard implementation does not become just a documentation activity but it becomes a way of life for the organization that lays a foundation for Total Medical Device Management and Medical Device Management conscious organizational culture.

ISO - Mumbai offers onsite consulting solutions and online consulting solutions for ISO 13485 certification. Our customers have been utilizing our services not only for initial certification consulting but also post certification consulting to ensure that our consultants regularly add value to the business processes of our customers and their process & quality standardization initiatives.

ISO – Mumbai’s ISO 13485 certificate consulting services include awareness training, medical devices management policy - objectives workshop, gap analysis, documentation design including manuals, procedures, work instructions, formats etc, implementation assistance & training, internal auditor training, assistance in conducting internal audit, pre-assessment audit and everything required to ensure a 100% successful ISO 13485 certification audit within scheduled project completion time period

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