Iso 13485 - Latest Quality Management System Certification For Medical Device Manufacturing | Global Coverage, Business Growth, Regulatory Compliance, Risk Mitigation, Enhanced Credibility, Legal Compliance
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Product Specifications
| Standard | ISO 13485 |
| Industry | Medical Devices |
| Coverage | Global |
| Format | Certification |
| Type | Quality System |
| Version | Latest |
| Usage | Medical device manufacturing and quality management system implementation. |
| Features | Quality Management, Regulatory Compliance, Risk Mitigation, Cost Reduction, Improved Relations, Legal Compliance, Enhanced Credibility, Business Growth |
Product Overview
Key Features
ISO 13485
ISO 13485 is a globally accredited Quality Management Strategy specifically designed for Medical equipment manufacturing. Its chief end is to streamline the compliance of regulatory requirements for the engineering of medical devices and equipment.
The standard determines precise requirements for development, fabrication, installation and servicing with certain directives like:
- Implementation of a Quality Management System with required improvement
- Calculated Risk Management for development and performance quality of products.
- Specific process validation
- Conformity with regulatory and statutory requisite
- Efficient implementation and maintenance of the system's requirement
Features
- Customer satisfaction goes higher through the delivery of product line that specifically match with customer's desire as well as assurance of better quality, safety and compliance of legal requirement
- Help in abating operating costs by dint of consistent enhancement of processes and operational effectiveness
- Assist in bettering relation with stakeholders spanning employees, clients and vendors
- Fulfilling legal compliance through deep insight in how regulatory provisions affect the companies and their customers
- Enhance risk management with the help of higher consistency and standard of products and efficient application of risk management technique
- Higher business credibility through independent validation against set standards
- Improving potentiality to gain more business, especially in the event of procurement necessitates the authentic certification as a terms for the supply in a highly regulated sector.
Company Details
IQA ADVISORS PVT LTD, Established in 2008 at Mumbai in Maharashtra, is a leading service provider of ISO Certification Consultants in India. IQA ADVISORS PVT LTD is one of Trade India's verified and trusted names for listed services. With extensive experience in the field of ISO Certification Consultants, IQA ADVISORS PVT LTD has made a reputed name for itself in the market with satisfactory Accounting Services, Brc Certification, Bsci Certification, etc.
Focusing on a customer-centric approach, IQA ADVISORS PVT LTD has a pan-India presence and caters to a huge consumer base throughout the country. Get ISO Certification Consultants from IQA ADVISORS PVT LTD at Trade India quality-assured services.
Focusing on a customer-centric approach, IQA ADVISORS PVT LTD has a pan-India presence and caters to a huge consumer base throughout the country. Get ISO Certification Consultants from IQA ADVISORS PVT LTD at Trade India quality-assured services.
Business Type
Service Provider
Establishment
2008
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Seller Details
Mumbai, Maharashtra
Director
Mr. Dinesh Bhangdiya
Address
D-252, Solaries-1, Saki Vihar Road Powai, Andheri (East), Mumbai, Maharashtra, 400072, India
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