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Ocean Management Services
Ocean Management Services


Product Certification Consultant Service

Leading Service Provider of iso 13485 certification service and ce marking from Ahmedabad.

ISO 13485 Certification Service

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ISO 13485 Certification Service
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Approx. Rs 70,000 / certificationGet Latest Price

We are a unique name in the industry to provide our valued clients the best quality ISO 13485 Certification Service. ISO 13485 is an international standard that specifies requirements for a quality management system that is used by any firm for the design and development, production, installation, and servicing of medical devices. ISO 13485 standard suggests that the management and application of a system of processes is an effective way to ensure best quality management. The offered service is available at most reasonable price.

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  • ISO 13485 is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices.
  • Based on the ISO 9001 process model, ISO 13485 standard suggests that the application and management of a system of processes is an effective way to ensure good quality management. This standard strongly infers that clients should consider using ISO 9000:2000 to ensure understanding of the Process Model, definitions and other items of concern, too.
  • This standard can also be used by international and external parties, including certification bodies, for assessment of the organization's ability to meet customer and regulatory requirements. The primary purpose of the ISO 13485:2003 standard is to facilitate harmonized medical device regulatory requirements for quality systems. All requirements of the ISO 13485:2003 standard are specific to organizations providing medical devices, regardless of the type or size.
  • ISO 13485 standard dictates that risk management must be thoroughly documented and conducted throughout a product’s entire life cycle, from initial concept to delivery and post-delivery. However, the standard leaves the specifics to a related standard, ISO 14971: 2001, Application of Risk Management for Medical Devices. While 13485 states that a manufacturer’s management team is charged with the management of device-related risks and the development of risk management plans, 14971 defines a list of steps to be taken by management in order to fulfill risk-related requirements.
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CE Marking

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CE Marking
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Approx. Rs 40,000 / NoGet Latest Price

Organizations looking for CE Marking certificate consultants in India, CE marking certification in India, CE marking certification registration provider consultant agency in India, CE marking certification with notified agency/ body in India, CE Marking self certification in India, CE marking certificate provider & CE marking service provider agency in India can contact us. We are a leading CE marking product certification consultants, CE Marking product certification consultancy service providers, CE marking training providers in India. We are providing CE marking consultancy services in India at Gujarat( Ahmedabad, Vadodara-Baroda, Surat, Ankleshwar, Bharuch, Nadiad, Anand, Vidyanagar, Mehsana, Kadi, Kalol, Chhatral, Palanpur, Rajkot, Bhavnagar, Jamnagar, Himmatnagar, Bavla, Gandhinagar, Gandhidham, Kutch, Mundra, Surendranagar, Junagadh, Saurashtra and in other cities of Gujarat ) , Rajasthan, Madhya pradesh , Uttar pradesh, Haryana, Punjab, Bihar, Maharashtra, Kerala, Tamilnadu, Andhra pradesh, and in other states of India. Depending upon application and design of product under consideration, we can help organization in identification of proper directives and harmonic standards applicable to the product and performing gap analysis against requirement of directives and existing product. We will be responsible for coordination with notified body ( where notified body involvement comes) for smooth and faster execution of CE marking certification project.Ocean Management Services For CE Marking in Ahmedabad, CE Marking in Gujarat.

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Ocean Management Services
Krushnakant Vaghela (Director)
50, Astha 2 Complex, 2nd Floor, Ratanpura Cross Road , Mahadev Nagar Tekra,
Ahmedabad - 382418, Gujarat, India
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