ISO 13485 Mumbai

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

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.
  

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

  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