ISO13485:2016 Medical Devices

The Benefits of ISO 13485:2016?

  • Meet customer and regulatory requirements
  • Increase efficiency, cut costs and monitor supply chain performance
  • Outline how to review and improve processes across your organisation and products
  • Expand into markets worldwide by having an audited and certified management system in place

International Regulatory Advice

ISO 13485 is the internationally accepted standard a medical device organisation can implement to demonstrate compliance with MedTech legislations. Obtaining an ISO 13485 Certification ensures worldwide recognition for your organisation compliance with ISO 13485 requirements. It also represents a solid starting point if you are thinking of applying for MDR, IVDR or UK MDR: European Regulations: (MDR) (EU) 2017/745 and (IVDR)(EU) 2017/746 UK Regulation: UK MDR 2002.

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iQMO offers simple, efficient ISO13485 Implementation Consultation

Our team of experienced IRCA Lead Auditor Consultants will ensure you achieve UKAS Accredited Certification with minimum fuss. We do the heavy lifting so you can focus on what you do best.

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ISO13485 Implementation Consultation in preparation for Certification

ISO13485 UKAS Certification Advice Support and Guidance

Internal Auditing of your ISO13485 System

Audit Support for Annual Surveillance and Re-Certification Audits

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What is ISO13485:2016?

A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.
International and local regulatory requirements are increasingly more stringent at every step of a medical devices product’s life cycle, including development, service and delivery. ISO 13485 is the most widely used international standard for quality management in the medical device industry.
Organizations in the industry are now increasingly expected to provide evidence of their quality management processes and ensure best practice in everything they do and this important international standard is an effective solution which meets the comprehensive requirements for a QMS in the medical device industry.

Who is ISO13485 for?

Safety and quality are foremost in the medical devices industry with organisations involved in the design, production, installation and servicing of medical devices and related services.
ISO 13485 is important to designers, manufacturers, and distributors of medical devices.
Adopting ISO 13485 provides a practical foundation to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

ISO13485 Certification

Achieving third-party ISO 13485 Certification provides an ideal foundation for manufacturers and can demonstrate to regulators that you have met the requirements of the standard to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.
It is essential that your ISO13485 Standard be implemented and maintained with professional Internal Auditing by qualified and experienced Auditors.

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