Iso 13485 Certification Service In India
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Product Specifications
| Standard | ISO 13485 |
| Scope | Medical devices |
| Version | 2016 |
| Certification type | Registration |
| Validity | 3 years |
| Geographic coverage | India |
| Usage | Ensures medical device manufacturers meet international safety and quality standards. It aids in compliance with global regulations and improves business processes. |
| Features | Risk reduction, Compliance aid, Improved quality, Global acceptance, Efficiency boost, Cost savings |
Product Overview
Key Features
We are involved in providing ISO 13485 Certification in India. ISO 13485 Certification is an international standard that specifies requirements for medical device manufacturers. ISO 13485: 2003 has been harmonized against the three Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices). The main difference between ISO 9001 and ISO 13485 is that ISO 13485 is more focused towards ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement. Once you implement processes and procedures that comply with the requirements listed in ISO 13485:2003.
ISO 13485 is becoming widely accepted as the international standard to address medical device regulations around the world.
Benefits of ISO 13485:
o Increased efficiency
o Cost savings
o More effective risk management and quality assurance
o An improved ability to respond to customer requirements are just a few of the potential results that certification to the standard can bring.
o Certification to ISO 13485 satisfies a significant portion of the EU Directive requirements for marketing medical devices in Europe.
ISO 13485 is becoming widely accepted as the international standard to address medical device regulations around the world.
Benefits of ISO 13485:
o Increased efficiency
o Cost savings
o More effective risk management and quality assurance
o An improved ability to respond to customer requirements are just a few of the potential results that certification to the standard can bring.
o Certification to ISO 13485 satisfies a significant portion of the EU Directive requirements for marketing medical devices in Europe.
Company Details
4B SOLUTIONS, Established in 2009 at New Delhi in Delhi, is a leading service provider of ISO Certification Consultants in India. 4B SOLUTIONS is one of Trade India's verified and trusted names for listed services. With extensive experience in the field of ISO Certification Consultants, 4B SOLUTIONS has made a reputed name for itself in the market with satisfactory 17025 NABL Accreditation Certification Consultants, BRC (British Retail Consortium) Certification , CE Certification in India, Delhi, etc.
Focusing on a customer-centric approach, 4B SOLUTIONS has a pan-India presence and caters to a huge consumer base throughout the country. Get ISO Certification Consultants from 4B SOLUTIONS at Trade India quality-assured services.
Focusing on a customer-centric approach, 4B SOLUTIONS has a pan-India presence and caters to a huge consumer base throughout the country. Get ISO Certification Consultants from 4B SOLUTIONS at Trade India quality-assured services.
Business Type
Service Provider
Establishment
2009
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Seller Details
New Delhi, Delhi
Accepts only Domestic inquiries
Partner
Mr. G S Sharma
Address
office no- 18/1, IV FLOOR, GOVINDPURI, KALKAJI, New Delhi, Delhi, 110019, India
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