Medical devices have become an increasingly important health care area in relation to their impact on health and health care related areas. The sector covers thousand types of products, ranging from simple bandages and spectacles, through life maintaining implantable devices, equipment to screen and diagnose disease and health conditions, to the most sophisticated diagnostic imaging and minimal invasive surgery equipment.
Organizations in the medical device sector including manufacture of product or service providers are confronted with a variety of relevant quality management system standards that are intended to satisfy organization, customer, and regulatory agency objectives. URS portfolio of schemes related to Medical Device manufactures and service providers are as below:
• ASSESSMENT & CERTIFICATIONS
Certification Under Medical devices covers:
Quality Management System
The ISO9001certification aims at providing a global standard that spells out quality and trust. It is a quality management system standard and is applicable to all type of organizations.
Environment Management System
A system compliant to ISO14001is a management system dedicated to manage the environmental issues of an organization.
Occupational Health & Safety Management System
OHSAS18001 is a globally recognized standard for occupational health and safety management system and defines the health and labor protection system of an organization. An OHSAS18001 certification establishes an organization's commitment to provide a safe working environment to protect employees & other concerns.
Quality Management System for Medical Devices Manufacturers
The ISO13485 is a quality system, standard for organizations that design, produce or service medical devices. It intends to promote harmonization in medical device industry and set a basis for quality system regulations worldwide.
Information Security Management System
A certified Information Security Management System compliant to International Standard demonstrates that information is suitably protected. ISO has developed ISO27001 standard in order to overcome the information security shortcomings in organizations.
Compliant Management System
ISO10002 Complaints Management System provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance and improvement.
HSEQ - Business Branding
HSE-Q Health, Safety & Environment with Quality has become the core business area and has achieved a global status as a Recognized Profession. Adherence to HSE-Q concept is essential tool to success and paves the way of becoming a dominant market leader.
• PRODUCT CERTIFICATIONS
The Process of Certifying that a Certain Product has Passed Performance and/or Quality Assurance Tests or Qualification Requirements.
URS Provides Product Certifications like: CE Certification and GOST- R Certifications.
An inspection programme is "Checking a product or system against the standards set by the International or National Organization or itself". URS provides both second & third party inspection services.
• COMPLIANCE AUDITING
Compliance Audit is to determine whether the Auditee is following Prescribed Laws, Regulations, Policies, or Procedures. Compliance Audits can be performed Within Business Organization for Internal Purposes or in Response to Requirements by Outside Groups, Particularly Government.
URS Offer Compliance Auditing and Certification for:
cGMP, ROHS, C-TPAT and ISO 3834- Welding Process Compliance
Training is a medium to enhance the skills and competence of an individual. URS Training & Development Division trains, mentors, evaluates and certifies individuals including Managers, Entrepreneurs, and individuals of Companies, Corporations & Educational Establishments.