ISO 13485 - Medical Devices Quality Management System

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ISO 13485 overview

ISO 13485 is an international standard which provides a quality management system framework for organisations that work within the medical device supply chain. The medical devices industry has experienced growth worldwide, and maintaining a high-standard of quality has become even more crucial. Regardless of whether your business is big, small, government-run or an NGO, gaining and maintaining ISO 13485 certification shows that your organisation values the importance of offering high-quality equipment and is committed to maintaining continuous improvement. Using a holistic approach, this standard provides a comprehensive framework for managing the quality of medical devices in a structured manner. 

ISO 13485 Benefits

Every company within the medical devices supply chain is responsible for the quality of the medical devices. Yet, whilst having solid Medical Devices Quality Management System procedures in place is crucial for providing an excellent medical or retail service, you will find that the benefits also extend to the running of the organisation itself. As ISO 13485 is designed to help businesses run more smoothly and efficiently through higher-quality equipment, these are a few benefits that this standard can bring to your organisation: 


The ISO 13485 standard is designed to be used by organisations involved in the design, production, installation and servicing of medical devices and related services. In fact, without restricting itself to fixed requirements and mandates for each industry, ISO 13485 uses a flexible approach that may be used by all within the medical devices supply chain. Accordingly, there are several related industries for whom this certification could prove essential. 

Work with An Expert

For some companies, it might be tempting to read the standard and attempt to implement these processes without receiving any expert s organisations within the health industry routinely make use of medical devices, implementing this well-structured management system is crucial to maintaining a high-level of standard across the board.. However, this is typically not enough to implement an efficient, long-term management system. A literal interpretation of this standard may easily create an overly bureaucratic management system, yielding the opposite results of what would otherwise be achieved. Instead of a structured system based on the smart analysis of data, you could end up with an overly complicated and inefficient system. 

Instead, hiring an expert consultancy with years of experience is the best way to effectively meet your ISO standards. Make sure to choose an expert you trust, to provide you with a grounded approach that will simplify your life, rather than over-complicate it. 

Certification Bodies

When looking to get ISO certification, choosing to work with the right certification body is a crucial part of the process. It is important to make sure that your certification body is fully accredited, as only these entities are truly qualified to provide ISO certification.

Throughout his career, Luke has created internationally recognised management systems and in turn, has helped his clients to gain ISO certification with all of these internationally recognised certification bodies. Regardless of which certification body you choose to work with, Luke’s 100% money-back guarantee will always apply!


As a Malta Enterprise approved advisor, Luke can help his clients reap the full benefits of currently available funding. Applicable to any business based in Malta, the Government of Malta’s current funding schemes have never been better. The precise amount depending on your company’s size and ownership structure. 

For more information, simply get in touch for a free consultation session! Luke will help you to make the most of the best available funding incentives applicable to your business.


Luke’s approval as a Malta Enterprise approved advisor means that his clients can reap the full benefits of currently available funding schemes. Find out whether you are eligible for funding by getting in touch with Luke!

Funding Opportunities

For companies that are committed to offering consumers high-quality medical devices, getting ISO 13485 certification is a crucial milestone. Recognizing the importance of working towards this standard, there are various funding opportunities to be found in Malta. These include:  

  • 50% Tax Credits by the Government of Malta.
  • cash grants by Malta Enterprise, JobsPlus, & other entities.
ISO 13485 Malta

ISO 13485: A Closer Look

What Topics Does It Cover?

Published in March 2016, the ISO 13485:2016 Medical Devices Quality Management System remains the most recent and up-to-date version of this standard. Using a high-level system that allows it to be easily implemented alongside other ISO management systems, this standard follows the same ‘Plan-Do-Check-Act’ model which defines all of the revised ISO standards. The following shows a brief overview of the topics the ISO 13485 covers: 

  • The need to contextualise the organisation’s Medical Devices Quality Management System and define its overarching scope. 
  • How to establish management roles and responsibilities through high-value quality policies, objectives, reviews and system resources. 
  • How to manage resources including human resources, infrastructure, work environment and contamination control.  
  • Product planning by establishing the quality requirements for your product(s), defining the required processes and documentation needed, outlining the required company infrastructure,  employee qualification and training requirements.  
  • Evaluating the finished product through verification, validation, measurement, monitoring, handling, inspection, storage, distribution, and traceability.  
  • Maintain efficiency systems in place to produce consistent, high-quality products. 

Achieving ISO 13485

What Does This Say About Your Organisation?

Although achieving ISO 13485 accreditation is not a legal requirement, owning this certification says a lot about what type of business you are running. Adhering to this standard boasts inherent benefits but it also sends the right message to you clients, investors and competitors.  Getting ISO 13485 certification proves that your organisation: 

  • Values the importance of high-quality medical devices. 
  • Is compliant with medical device quality statutes and requirements. 
  • Understands the business related benefits of producing, distributing or using medical devices of a good quality. 
  • Is an industry leader which operates at a level of excellence by offering the best quality medical devices. 

Additionally, achieving ISO13485 certification will assist your business in regulatory compliance with respect to:

Medical device regulations malta

Frequently Asked Questions

Every company within the medical devices supply chain is responsible for the quality of the medical devices. In fact, ISO 13485:2016 is aimed towards all organizations within the medical supply chain, including design and development, manufacturing, storage and distribution, installation, servicing, disposal and technical support. This helps all companies to maintain a high quality service across-the-board.

Your ISO 13485 certification will need to be renewed after a period of three years. To maintain your certification, an assessment must be conducted once a year and recertification is issued every three years to ensure that your management systems continue to operate within the ISO 13485 required standards. 

Yes, like other ISO standards that are concerned with different types of management systems - including ISO 9001 and ISO 14001 - the ISO 13485 uses a high-level structure. This indicates that the ISO 13485 may be effortlessly integrated within any existing ISO management system. 

The amount of time it takes your company to earn your certification all depends on the size and complexity of your business. Luke will help you to make this process as swift and efficient as possible for your convenience.

Whilst organisations can attempt to optimise their medical device quality management systems without certification, ISO 13485 provides a structured approach which is sustainable and internationally trusted. 

Therefore, although it is not necessary, it is a recommended tried-and-tested means of achieving good quality management. 

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