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The medical devices industry is complex, evolving, and filled with challenges. However, making an impact and remaining competitive means never standing still.

Key challenges in the medical devices industry

Trying to innovate, keep costs down and remain competitive can cause a lack of control over the quality of materials or processes in the medical device industry. As the industry evolves, organisations will encounter all kinds of challenges. Key challenges include:

  • Changing requirements of regulatory agencies 
  • Being compliant-ready to meet changes such as the EU MDR 2021 transition 
  • Increasingly smaller parts requiring additional Standards for precision engineering

Remaining compliant and meeting regulatory obligations is challenging for any organisation in this space, where an overhaul of current processes, systems and management may be necessary.

Importance of Standards in medical device engineering 

Medical device engineering requires organisations to navigate a complex maze of regulations and Standards through every stage of manufacturing in the supply chain. Every component, no matter how small or inexpensive, can be life critical. 

The enforcement of stricter safety and quality standards are set in place to keep the end user safe. Not meeting these can result in litigation or worse, harm to the user. 

Key medical device engineering Standards 


  1. ISO 14971:2019 specifies terminology, principles and a process for risk management of medical devices.
  2. ISO/DIS 20417:2019 sets requirements for the information to be provided by the manufacturer
  3. ANSI/AAMI ST67:2019 specifies requirements and provides guidance on selecting approaches to establish assurance of sterility for a health care product labelled as “sterile.” 
  4. The ISO 16142 set of Standards focuses on the recognised essential principles of safety and performance of medical devices. 
  5. AAMI EQ93:2019 provides definitions for key terms used in medical equipment management around the maintenance, repair and servicing of medical devices. 

Standards driving the way forward for medical device companies 

Through providing guidance on best practice, Standards can be utilised to push forward in this changing environment and remain competitive. They can assist in overcoming challenges and present information to facilitate  organisational problem solving and operational efficiencies.  

The importance of Standards for the medical device engineering industry is undoubtable. They can help address key challenges and shape the response. Without these guidelines, producing a product safe for the end user would be impossible. 

The need for a Standards management solution is essential. Features such as real-time notifications of changes to Standards, plus access to Standards anytime and anywhere are important to continually meet requirements and stay up to date in the industry.

Learn how a Standards Management Solution can assist with engineering challenges.
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Stay up-to-date in a fast-changing industry and gain access to the Standards you need

ISO 14971, the updated Standard for the application of risk management to medical devices

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