Legal Status of Firm
Limited Company (Ltd./Pvt.Ltd.)
Year of Establishment
2017
Annual Turnover
Rs. 1 - 2 Crore
Indiamart Member Since
Apr 2017
ISO 13485:2016 Certification Service, For Manufacturing
Mode of Report | Hard Copy |
Type of Industry | For Manufacturing |
Type of Certification | New Certification |
Services offered | Consultancy |
Training Courses (if applicable) | ISO 13485 |
The main objective of standard ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. All requirements of ISO 13485:2016 are specific to organizations providing medical devices, regardless of the type or size of the organization. Perhaps more than any other type of manufactured product, the quality of medical devices has a direct impact on their effectiveness as well as the safety of patients, users and, where appropriate, other persons. For these reason, most national regulatory schemes require manufacturers and suppliers of medical devices to establish an internal quality management system that has been independently audited and verified. Medical devices manufactured or supplied by organizations without a verified quality management system are routinely denied legal entry into major markets, usually resulting in extended delays in gaining access and lost revenue opportunities. What is ISO 13485:2016:
- Quality management systems for medical devices manufacturers – Requirements for regulatory purposes, addresses the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers. ISO 13485:2016 is similar in scope and intent to ISO 9001, but it includes additional requirements specific to medical devices while excluding certain ISO 9001 provisions. Therefore, in most jurisdictions, ISO 9001 certification is not an acceptable substitute for certification to the requirements of ISO 13485:2016.
How can we help you?Eucert’s technical professionals have first-hand knowledge and in-depth expertise with all types of medical devices. In addition, we are a leading management certification body for quality management systems, including management systems applicable in the manufacture of medical devices. Each audit team consists of experts with the skills & expertise needed to accurately assess the, and is headed by a lead auditor who will oversee the audit and any required management change notices. It makes Eucert ideally suited to address the needs of medical device manufacturers seeking to achieve or maintain ISO 13485:2016 certification.
Major Benefits: - Improve efficiency and marketability: With formal certification of your quality management system that will help you to market your products and services and improve the efficiency of your organization.
* Get benefits from expert partnership: With our experienced audit team to identify both non-conformities as well as opportunities for improvement.
* Gain a single source solution: With auditing and testing services that address compliance requirements with international standards and regulations applicable in all major medical device markets.
Product Details
Company Details
Product Specification
Mode of Report | Hard Copy |
Type of Industry | For Manufacturing |
Type of Certification | New Certification |
Services offered | Consultancy |
Training Courses (if applicable) | ISO 13485 |
Document verification Mode | Offline |
Target Location | Pan India |
Certifications Provided | ISO 13485 |
Service Duration | 15 - 30 days |
Service Mode | Offline, Online |
Service Location | All Over the World |
Minimum Order Quantity | 1 |
Product Description
The standard ISO 13485:2016 Certification Service 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 main objective of standard ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. All requirements of ISO 13485:2016 are specific to organizations providing medical devices, regardless of the type or size of the organization.
Perhaps more than any other type of manufactured product, the quality of medical devices has a direct impact on their effectiveness as well as the safety of patients, users and, where appropriate, other persons. For these reason, most national regulatory schemes require manufacturers and suppliers of medical devices to establish an internal quality management system that has been independently audited and verified. Medical devices manufactured or supplied by organizations without a verified quality management system are routinely denied legal entry into major markets, usually resulting in extended delays in gaining access and lost revenue opportunities.
What is ISO 13485:2016:
- Quality management systems for medical devices manufacturers – Requirements for regulatory purposes, addresses the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers. ISO 13485:2016 is similar in scope and intent to ISO 9001, but it includes additional requirements specific to medical devices while excluding certain ISO 9001 provisions. Therefore, in most jurisdictions, ISO 9001 certification is not an acceptable substitute for certification to the requirements of ISO 13485:2016.
How can we help you?
Eucert's technical professionals have first-hand knowledge and in-depth expertise with all types of medical devices. In addition, we are a leading management certification body for quality management systems, including management systems applicable in the manufacture of medical devices. Each audit team consists of experts with the skills & expertise needed to accurately assess the, and is headed by a lead auditor who will oversee the audit and any required management change notices. It makes Eucert ideally suited to address the needs of medical device manufacturers seeking to achieve or maintain ISO 13485:2016 certification.Major Benefits:
- Improve efficiency and marketability: With formal certification of your quality management system that will help you to market your products and services and improve the efficiency of your organization.
- Get benefits from expert partnership: With our experienced audit team to identify both non-conformities as well as opportunities for improvement.
- Gain a single source solution: With auditing and testing services that address compliance requirements with international standards and regulations applicable in all major medical device markets.
Additional Information
Item Code | 97 |
Delivery Time | Vary |
Production Capacity | Any |
About the Company
Eucert ICSPL is an Independent Assessment and Certification Body offering value added services worldwide. Eucert was formed with the objective to operate as a Registrar that was truly receptive to client's needs, in particular, the need to understand a business process and to ensure systems are in place, that too in delivering its services while not hampering client’s operation. Eucert provides global assessment and certification services in the field of:
- Management System Certification
- Product Certification
- Social Compliance Audits
- Inspections
- Trainings
Eucert ICSPL provides diverse services in Management Systems –
- ISO 9001:2015
- ISO 14001:2015
- ISO 45001:2018
- ISMS 27001:2013
- ISO 50001
- ISO 22000:2005 and many more.......!
Trainings like-
- ISO Lead Auditor & Internal Auditor & Awareness Courses
- Welding Trainings
- Welder Qualifications as per EN/IS/AWS and other standards.
- CE Certification Training
- 5S training
- TQM/FPC training
- API training
- CWB/CSA training and many more.........!
Third Party Inspection
Product Certification
- CE marking as per various directives
- CPR Construction product Regulation - 305/2011
- Machinery Directive - 2006/42/EC
- Low Voltage directive 2014/35/EU
- EMC Directive
- ATEX Directive
- PED Directive
Eucert can sharpen your competitive edge:
- With reliable testing and certification for faster regulatory approval
- Through rapid, efficient entry to virtually any market in the world
- With Total Quality Assurance across your supply chain
- Through innovative leadership in meeting social accountability standards
- By reducing cost and minimizing health, safety, and security risks
- By becoming a trusted brand
Eucert Inspection & Certification Services Private Limited is one of the largest reputed Certification Bodies in India, Eucert has been closely associated with the quality revolution in India starting with some of the earliest ISO 9001 audits by any certification body in India. As third-party, independent company, we deliver our services in full compliance with the principles of professional ethics, transparency, confidentiality and social accountability. Eucert operating in all countries and maintains highest value of reliability in its assessment process. Clients certification cover all industrial, Transport, Aerospace, Banking and other Service Sectors- Private, Semi Govt and Government. Eucert works with the concept of Operational Safety, which presents customers with considerable added value including significant financial savings, and safe and smooth business operations. Services of Eucert are Impartial, Independent, Fair, and Cost Competitive to build quality & competent processes in today’s competitive environment. Eucert ICSPL is the company that delivers services of classification, certification, testing and inspection to guarantee excellence to organisations in the marine, environment and energy, infrastructures, transport and logistics, quality and safety and agri-food sectors and other various sectors.
Eucert’s qualified and experienced pool of experts partner you with our services to ensure that your operations are running at maximum efficiency, safety and quality.