ISO 13485:2013 Consultants

ISO 13485 Certification

OVERVIEW-It is a management system standard which is specifically made for manufacturer engaged in business of manufacture of devices used for medical purpose. ISO 13485:2013 Certification tends to help a company achieve efficiency and also increase its profits. It is considered to be part of management system. With ISO 13485 Certification, companies are able to fullfill customer expectation and regulatory requirements related to medical machinary and some other products related to it. It also gradually helps in improving quality of the products.

Irrespective of size and type of business, manufacturer engaged in following class of business are required to obtain ISO 13485:2013 Certification

  1. Companies engaged in manufacture of medical device
  2. Companies engaged in pharmaceutical business

ISO 13485:2013 Certification Requirements

Following requirements must be fulfilled in order to get ISO 13485:2013 Certification

  1. Comply all the legal requirements related to ISO 13485:2013 Certification
  2. System of effective product traceability and recall system,
  3. Quality management system should be installed.
  4. All process and procedures followed in work area should be properly validated.
  5. Product development should be subject to risk management plan.

Apart from statutory requirements ISO 13485:2013 Certification it has many other benefits.

  • As there is no compromised with quality of the products, hence customer satisfaction is assured.
  • It ensures various compliance and statutory requirements for specified companies in this behalf.
  • Its focuses on area of cleanliness and safety at workplace which eventually leads to safety at workplace.
  • It increases risk management techniques within workplace.
  • It helps in reducing overall cost of manufacturing.
  • It increases revenue of the business.
  • It increases goodwill and brand value of the business.
  • It saves in litigation costs.
  • It leads to ethical  business practices
  • It helps business grow in long run.
  • It tends to move business from supply driven market to demand driven market which eventually improves economy of the country as a whole.
  • It forces business to use  good manufacturing practices in doing business.
  • Customers safety is not compromised but improved.

ISO 13485:2013 Consultants

With ISO 13485:2013 Certification being made mandatory for specified business, there has been drastically increase in demand for ISO 13485:2013 Consultants. We at ISICERTIFICATION help those businesses and companies who are intending to get ISO 13485:2013 Certification. We help in important matters related to getting ISO 13485:2013 Certification. We serve all types of clients notwithstanding with their place of business and their type and size. Our team consist of professional expert who provide best consultancy in the market and help you in lowering down overall cost in getting ISO 13485:2013 Certification.

One thing which has been our principle since the day one is the satisfaction of our customers which has lead us to become one of the best ISO 13485:2013 Consultants within very short span of time.
ISO 13485:2013 Consultants by State
Andaman and NicobarAndhra PradeshArunachal Pradesh
ChhattisgarhDadra & Nagar HaveliDaman and Diu
HaryanaHimachal PradeshJammu and Kashmir
LakshadweepMadhya PradeshMaharashtra
Tamil NaduTripuraUttar Pradesh
UttarakhandWest Bengal