ISO 13485 – Medical Devices Quality Management Systems

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Sylvain
Manager, Global HSE

Medical Devices Quality Management Systems

An effective solution to meet the comprehensive requirements of QMS is the ISO 13485 standard. Manufacturers that adopt ISO 13485 are provided with a pragmatic foundation for the regulations and responsibilities towards the addressing and also demonstrating their commitment to quality and safety of medical devices.

ISO 13485 certificates are renown and trusted in industries involved in medical devices and manufacturers, suppliers and authorities around the world.

ISO 13485 is an individual QMS standard that is derived from ISO 9000 standard series which is recognized and accepted internationally. It adapts the ISO 9000 model based on process into a regulated environment for manufacturing medical devices. ISO 13485 is a more prescriptive in nature and often does require a rather thorough documentation of the QMS system. While retaining the Plan, do, check concepts of ISO 9001, It is designed for regulatory compliance.

ISO 13485 was transcribed singularly to manufacturers of their designing of quality management systems that effectively establish and maintain their processes. It ensures the consistency design and development, production, delivery and installation of medical devices in a manner that is safe for their intended purpose

What are Significant Features of ISO 13485?

Specific requirements for documentation and validation of processes for sterile medical devices
Focus on risk management activities and design control activities during product development
Market-specific regulatory requirements includes Medical Devices Directive 93/42/EEC
ISO 13485 is Mandatory is to sell the products in EU
Controls in the work environment to ensure product safety
Provides validation of corrective and preventive action

Key Benefits of ISO 13485

  • Certification increases access to worldwide markets

  • Process review and improvement outline across your organization

  • Monitor supply chain performance, increase efficiency and cut costs.

  • Demonstration of safer and effective medical device production.

  • Meeting customer expectation and Regulatory requirement.

Who can Use ISO 13485 Certification?

  • ISO 13485 Quality Management System –Medical Devices is designed by experts which can be used by any organisation, which handles process of Medical Devices manufacturing , Reselling , Exporting to European Business Market Namely, irrespective of their size or geographical location.

How Vegas CG Can Help You?

You get much more than just a certificate with Vegas CG as your audit and certification partner, Vegas CG provides valuable tools to reduce documentation, and helps identify cost savings, and provides assistance in avoiding deviation of an original process.

Our Team of experts function as part of your management team and help your orginisation achieve greater benefits of the management system.

Certification process

VCG shall initially review the client enquiry and send them a questionnaire for their completion. Based on the completed questionnaire from the client VCG will take a decision for certifications, for which a quote will be sent to the client for 3 years of certification period. Click here to know more information about the certification process.

Conformity Assessment Stages & Cycle

STAGE 1 – Document review & Initial visit

  • To verify how well the organisation has understood requirements of the standard and there progress.
  • Collect information on the scope of the management system, organisations related statutory, regulatory and legal compliance aspects.

REPORTING

  • Detailed Report will be prepared and communicated by end of the Man-day by the audit team.
  • The Duration for Stage 2 Audit will be decided based on the Non-Conformance raised during Stage 1.

STAGE 2 -Initial Assessment – On Site

  • To evaluate the implementation and effectiveness of your management system.
  • To evidence that the management system conforms to the standard & other requirements.
  • Conformance to internal auditing and management review management responsibility for your organisation’s policies

REPORTING

  • The Report records the results of the assessment, any areas for improvement and any identified and agreed non-conformities.
  • Detailed Report will be prepared and communicated by end of the Audit day by the audit team.

Themed Surveillance Audit

To make sure your management system is still effective, and to follow up on the progress that has been made since last visit. Visits occur at regular intervals of 1yrs from date of previous audit.

The surveillance visits aim to confirm that the approved management system continues to:

  • To be maintained
  • To be operational
  • Deliver continual improvements.

REPORTING

A detailed report will be submitted by the assessor’s team including long term improvement, record findings, Feedback to senior management. System weaknesses & impact that can adversely on the business.

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