Welcome to Amtivo in Ireland, formerly Certification Europe and EQA

cert eu logo eqa Logo white

ISO 13485

Medical Devices Quality Management

ISO 13485 is a globally recognised quality standard that outlines the requirements for a quality management system in the design, manufacture and installation of medical devices worldwide. With almost 30,000 certificates issued worldwide, this international standard ensures compliance with medical product and service regulations, demonstrating an organisation’s commitment to quality and customer satisfaction.

4.8_Feefo rating

Get Started Today

Enter your details below to get started on
your journey to certification.

What Is ISO 13485?

ISO 13485 is designed for organisations involved in the design, production, installation and servicing of medical devices. It provides a framework for implementing a Quality Management System (QMS), ensuring that medical devices meet regulatory requirements and maintain consistent quality across all organisations.

This certification for quality management of medical devices manufacturing provides a framework to help:

  • Demonstrate compliance with medical regulatory requirements.
  • Expand into new markets and participate in tenders requiring this ISO certification.
  • Enhance customer satisfaction and retention.
  • Benefit all sizes of organisations involved in medical device development, production and installation.
Amtivo (Formerly Certification Europe and EQA) ISO 13485 Medical Device - Medical worker operating a medical device.

What Are the Benefits of ISO 13485?

Product quality assurance

Product quality assurance

Compliance with regulations

Comply with regulations

Boosted customer confidence

Boosted customer confidence

Optimised processes and documentation

Optimised processes & documentation

effective risk management

Effective risk management

Global market access

Global market access

Continuous Improvement Culture

Continuous improvement

Enhanced supplier relationships

Enhanced supplier relationships

market surveillance v2

Efficient market surveillance

Market Competitive Advantage

Competitive edge

greater business opportunities

More business opportunities

Enhanced reputation

Industry recognition

Key Requirements of ISO 13485

The ISO 13485 standard outlines a number of requirements that organisations must meet to demonstrate their commitment to quality management system in the design, manufacture and installation of medical devices. These include:

tick-icon

Organisational context

Understanding the organisation’s external and internal unique conditions that influence its strategic direction and approach towards its quality management system.

tick-icon

Leadership

Leadership commitment to medical device quality management and continuous improvement, aligning policies with the organisation’s strategic objectives.

tick-icon

Process control

Implementing controls and procedures to ensure the consistent production and installation of specific medical devices to a high quality and safe-to-use standard.

tick-icon

Risk management

Identifying and mitigating risks associated with medical device manufacturing to comply with industry safety regulations and protect both employees and customers.

tick-icon

Performance evaluation

Regularly assessing and improving the performance of your Quality Management System (QMS) to ensure high-quality, safe-to-use medical devices.

tick-icon

Customer focus

Ensuring customer needs and expectations are identified and fulfilled to a high standard that benefits your business, including efficient customer service.

tick-icon

Regulatory compliance readiness

Preparing your organisation to effectively respond to and comply with medical product and service regulations as and when they are updated, protecting you from legal ramifications.

Why You Should Choose Amtivo

  • Ireland-based team that understands your needs
  • Free ISO management system software to simplify certification*
  • Five-star ratings, independently reviewed via Feefo
  • A wide range of training courses to build your expertise
  • Access to a global team with global resources
Why Choose Amtivo

Becoming ISO 13485 Certified

STEP 1
STEP 2
STEP 3
STEP 4
STEP 5
Stage One The initial assessment determines if the mandatory requirements of the standard are being met and if the management system is capable of proceeding to
Stage Two.
Stage Two The second assessment determines the effectiveness of the system, and seeks to confirm that the management system is implemented and operational.
Recommendation for Certification At this point in the process we review any corrective actions taken to address findings raised at Stage 1 & 2. Certification may be recommended.
Certification Review & Decision The organisations files are reviewed by an independent and impartial panel and the certification decision is made.
Certification Achieved Successful certification is communicated to the client. Certificates are issued.

STEP 1
Stage One The initial assessment determines if the mandatory requirements of the standard are being met and if the management system is capable of proceeding to
Stage Two.
STEP 2
Stage Two The second assessment determines the effectiveness of the system, and seeks to confirm that the management system is implemented and operational.
STEP 3
Recommendation for Certification At this point in the process we review any corrective actions taken to address findings raised at Stage 1 & 2. Certification may be recommended.
STEP 4
Certification Review & Decision The organisations files are reviewed by an independent and impartial panel and the certification decision is made.
STEP 5
Certification Achieved Successful certification is communicated to the client. Certificates are issued.

Implementing ISO 13485

Ensuring your quality management system is ready for ISO 13485 certification involves commitment from the entire organisation. Prior to certification assessments, you may want to consider a Gap Analysis assessment, a valuable tool to review the readiness of your management system before Certification Assessments. This analysis provides insights into areas that need improvement, ensuring a smoother certification process.

Medical devices 1

ISO 13485 FAQs

What is ISO 13485:2016 certification?

If an organisation is ISO 13485 certified, it has implemented a quality management system in line with these medical device requirements. This means its processes for ensuring the quality, safety and efficiency of medical devices have been assessed and recognised as reaching the high ISO standards.

ISO 13485:2016 is the most up-to-date version of this standard.

The current standard has significant changes from the previous version ISO 13485: 2003 and reflects the evolution of the medical device regulatory environment and the greater need for risk management and risk-based decision-making processes within the medical devices industry.

What are the ISO 13485 requirements?

Requirements of ISO 13485 apply to organisations regardless of their size and type except where explicitly stated. Wherever requirements are specified as applying to medical devices, they apply equally to associated services supplied by the organisation. The requirements may vary based upon the class of medical device, from a wheelchair to a pacemaker.

The processes required by this standard that applies to the organisation, but are not performed by the organisation, are the organisation’s responsibility and are accounted for in the organisation’s quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches to be addressed in the quality management system. It is the organisation’s responsibility to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

How long does the ISO certification last?

Certification for this ISO lasts for three years and is subject to mandatory audits to ensure compliance.

Sign Up to Our Newsletter

Enter your details below to ensure you stay up to date with all the latest certification news and expert insights.

Related ISO Certifications

ISO 9001

Certification to ISO 9001 is one way to demonstrate to stakeholders and customers that you are committed and able to consistently deliver high quality products.

ISO 1400

Want to better manage your environmental impact and lower costs? Amtivo offers comprehensive ISO 14001 certification, auditing and training.

ISO 45001

Comply with occupational health and safety regulations and reduce insurance premiums with an ISO 45001 certification.

ISO 50001

Reduce energy usage, lower operation costs and reduce your business's impact on the environment with an ISO 50001 Certification for energy management.

ISO 27001

Protect customer data, avoid security risks, demonstrate compliance and stay competitive with an ISO 27001 certification for your ISMS. Contact us for a free quote.

ISO 27017

Boost cloud data security and comply with strict data regulations with an ISO 27017 certification.

ISO 27018

An ISO 27018 certification helps secure Personally Identifiable Information (PII) data, protecting you from data breaches and lawsuits.

ISO 27701

Better protect sensitive data and reduce the risk of security breaches and legal costs with an ISO 27001 certified Privacy Information Management System.

ISO 20000-1

With an Amtivo ISO 20000-1 certification, your business can showcase its commitment to delivering satisfying and high-quality, yet cost-efficient, IT services.

ISO 22301

Protect your business from disruption and disaster with an ISO 23001 certification from Amtivo.

ISO 20121

An ISO 20121 certification for event sustainability management can help you reduce waste and energy usage, boosting your company reputation and delivering a competitive edge.