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ISO 13485:2016: Medical Devices

ISO 13485:2016: Demonstrate compliance with the stringent requirements of the medical devices industry.

Safety and quality are central and non-negotiable when it comes to medical device manufacturing.  Certification with Lloyd's Register to ISO 13485:2016 allows your organisation to demonstrate compliant processes and best practice across the board.


ISO 13485:2016 is an international standard which defines quality management system (QMS) requirements for manufacturers of medical devices.  The new version, published in 2016, aims to provide an effective framework for manufacturers to address the strict regulatory requirement s of the medical devices industry.

ISO 13485:2016 was originally derived from ISO 9001 and shared many of the basic principles; however, it requires more thorough documentation and places more emphasis on areas such as the work environment, risk management, design control and regulatory requirements.

Whilst ISO 13485:2016 retains the structure of previous versions, it introduces several new elements to address industry requirements including:

  • A much greater emphasis on the need for a risk based approach to the QMS
  • Enhanced focus on the responsibilities and commitment of top management and to applicable regulatory requirements
  • Increased controls over suppliers and outsourced activities
  • Emphasis on risk management throughout the product life cycle


What we offer

LR provides a wide range of ISO 13485:2016 certification and training services designed to ease your journey towards compliance. 

At LR, we take time to understand the needs and unique circumstances of our clients and their businesses, to act with judgement, sensitivity and care.

Our independence means that we’re committed to doing things the right way to reach the highest standards and best outcomes for all, giving our clients confidence in our decisions every time.

We specialise in management systems compliance including gap analysis, assessment and certification, all underpinned with expert advice designed to meet the needs of your industry. 

We explore every problem thoroughly with exact, analytical precision.  We leave no stone unturned and no questions unanswered, to draw accurate conclusions.

We provide practical client training courses worldwide in various languages, led by trained and qualified tutors. Many of our courses are endorsed by relevant professional bodies and based on our experience of assessing management systems. We offer both public and in-house training services including customised training solutions.

Customised assurance
The challenge of globalisation, changing customer requirements, legislation and technology means that worldwide, organisations are increasingly turning to customised assurance programmes, underpinned with client specific criteria, to help them meet their organisational goals.

Our range of customised solutions are focused on delivering client value by offering a variety of tools and techniques to identify the right solution for your business. Once we have assessed your needs, we can then identify the most appropriate methods to equip you with the relevant knowledge and implement the recommended improvement initiatives.

A wide range of assurance services
Don’t let your certification journey stop with quality; at LR, we deliver certification, validation and verification assessment services to all of the world’s leading standards and schemes including health and safety, environmental, sustainability, energy management, business continuity, cyber security and many more.  

What are the benefits?

A licence to trade
ISO 13485:2016 is quickly becoming an essential pre-requisite for doing business within the medical devices industry. With more and more manufacturers requiring suppliers and service providers to be certified to ISO 13485:2016, it has become a viable means to provide competitive advantage and enhance marketability.

Increased confidence for manfacturers
Patient safety greatly depends on the quality and consistency of medical products. As a result, the value of ISO 13485:2016 certification is not just in its implementation, but the higher level of confidence it provides manufacturers in ensuring organisations will consistently achieve and maintain compliance.

Minimised risk for both patients and manufacturers
ISO 13485:2016 can help to prevent incidents from occurring – this keeps patients safe and minimises the risk of reputational damage to the manufacturer.

Why choose LR?

Technical expertise
LR is accredited by United Kingdom Accreditation Service (UKAS) and Standards Council of Canada (SCC) to provide ISO 13485:2016 certification, and by SCC and Health Canada to provide CMDCAS certification. Our assessors are industry specialists who are matched with your business needs, enabling an effective and robust audit of your system.  We’re expert in not only understanding the potential in cutting-edge ideas, but applying this pragmatically in ways which guarantee impact today and in the long-term.

Your business helps LR to help others
The profits we generate fund the Lloyd’s Register Foundation, a charity that supports engineering-related research, education and public engagement around everything we do. All of this helps us stand by the purpose that drives us every single day: working together for a safer world. 

Independent & Impartial

We maintain our independence and impartiality by proactively managing conflicts of interest across all LR businesses including those which may exist between consultancy and third-party certification services.  We will not offer consultancy services for any management system that is in the process of or has completed accredited third-party certification with LR. Further, if we are already providing consultancy services relating to a management system, we will not offer any accredited third-party assessment services.

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