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ISO 13485 certification- Best standard for medical devices

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ISO 13485 certification- Best standard for medical devices

The most deemed standard for medical devices is ISO 13485. The standard widely initiates to inculcate a quality management system for medical devices. ISO 13485 Standard is flexible for both small and big organizations dealing with manufacturing, designing, and packaging of medical devices. The accomplishment of ISO 13485 Certification clearly exhibits that the company works consistently to meet all the requirements of the customers and sustainably proffer quality. One thing to note is that the organizations exporting medical devices to other countries need mandatory accomplishment of the ISO 13485 Standard. 

All the medical devices like an instrument, apparatus, equipment, implant used to prevent, diagnose or treat a medical condition can certify themselves with ISO 13485 Standard. 

Some major advantages of getting certified with ISO 13485 Standard-

Companies that hold ISO 13485 certification enjoy some benefits like:

  • Complies with the legal requirements and medical devices regulatory norms
  • Mitigates the chances of uncertainty 
  • Risks based approach that helps in anticipating risks and eliminating them
  • Reduction in costs
  • Proffering quality products  
  • Manufacturing the devices and equipment according to international standard
  • Opportunity to accessible enter international market
  • Competitive edge among in the market
  • Boost in productivity and profitability
  • Improved processes

ISO 13485 Standard and risk management

ISO 13485 Standard greatly focuses on following an approach based on risk anticipation and management. A risk-based approach will help the certified company to focus on manufacturing or offering safety, quality, compliance and product efficacy. The normative procedures of ISO 13485 certification for medical devices will help your firm to minimize the errors and strategically meet the business objectives. The decisions based on a risk-based approach will be fruitful for the organization. 

ISO 13485 Standard requirements

Requirements of ISO 13485:2016 are apt for all organizations regardless of their size and regardless of their type. The ISO 13485 structure’s requirements are split into eight sections. The first three are introductory and the last five include the obligatory requirements for the Quality Management System.

Here is a list of 5 main sections:

Section 1: Quality Management System

Section 2: Management Responsibility

Section 3: Resource Management

Section 4: Product Realization

Section 5: Measurement, Analysis, and Improvement

Accomplish iso 13485 certification

  • Planning for the implementation of a quality system
  • Follow the regulatory norms
  • Implementation of the Standard
  • Documentation
  • Management Process
  • Certification Audit

To get a more comprehensive understanding of ISO 13485 certification for medical devices, its process, and procedure, click www.siscertifications.com We are a bunch of highly professional teams certifying the organizations around the globe with ISO Standards. Get your certification legally and ethically with SIS Certifications today. 

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