5 steps to the perfect standards process: How to update standards in medical technology

5 steps to the perfect standards process: How to update standards in medical technology

Updating and managing standards is one of the biggest challenges in medical technology. It is essential to ensure the safety and quality of products and to fulfil regulatory requirements. Nevertheless, the standardisation process is often underestimated. Outdated Excel lists and inefficient workflows mean that standards maintenance is reactive rather than strategic.

A practical example shows why a structured process is so important: the new version of ISO 10993-7 has introduced stricter limits for ethylene oxide residues. Ethylene oxide, a sterilising agent, can penetrate porous materials and cavities and remain there. These residues pose a considerable health risk, especially in products for newborn babies, whose body weight is often less than 2.5 kg. Manufacturers must ensure that no dangerous quantities of residual gases are released.¹ As many manufacturers have only documented that they use ISO 10993-7, but not which issue date, they cannot later verify in their documentation that their test procedure is outdated and does not include this important change. This shortcoming is often only noticed by auditors.

We will show you how to achieve an efficient and sustainable standards process in five simple steps - from reactive ‘fire-fighting mode’ to structured management.

1. Inventory and centralised documentation

Create a complete overview of all standards relevant to your products, including their current issue status. Determine which departments (e.g. Regulatory Affairs, Research & Development, Production) need to provide input. Bundle all relevant information on standards in a central location (‘single source of truth’) that all teams can access. Whether you use a specialised tool, a wiki or a software solution is up to you. The important thing is that this database is up-to-date, complete and accessible to all process owners.

This overview can also be used to record the countries, regions or regulatory frameworks for which the standards and requirements are applicable.

2. Correct application of standards

Ensure that all teams involved understand the importance of standards and their correct implementation. Regular training and workshops help to embed the necessary knowledge in the organisation and ensure that standards are perceived as an integral part of the product development process.

All teams should be familiar with the central database and always have access to the latest version of a standard. It is important that this is included in the product documentation.

3. Introduce regular monitoring

Schedule fixed dates to search for new versions of standards and evaluate them. Completely new standards that are applicable to you and may have been overlooked in the past can also be noticed. Monitoring can be done manually or using specialised software. It is crucial that this step is carried out regularly so that enough time can be planned for the implementation of any necessary changes.

💡 Free research or monitoring options

• Google Alerts: Receive automatic alerts to your email address for keywords you specify via Google Alerts.
• RSS feeds: Many standards organisations and authorities offer RSS feeds to stay informed about changes and new publications. Use an RSS reader such as Feedly to receive the RSS feed of the Medical Standards Committee of DIN e.V. or the Harmonised Standards of the EU.
• Manual: Of course you can also search manually at organisations such as ISO, DIN or FDA.

4. Maintain implementation documentation

Maintain systematic documentation on how each standard is implemented. This includes the relevant aspects of the standard as well as its practical application to your products. A standardised form can save a lot of time and effort here and also ensure the traceability of the process later on.

Extra tip:
Download our free implementation template and organise your standards process clearly, transparently and efficiently!

5. Efficient implementation

Depending on the scope of the standard, the necessary changes can be made quickly - but what if you need to make large-scale changes to product files? In a paper-based world, this can quickly lead to the need to revise several hundred documents. This is where it pays to manage files digitally.

Conclusion: From compulsory exercise to strategy

An efficient standards process is more than just a compulsory regulatory exercise - it is a strategic advantage. Companies that take a proactive and structured approach to standards updates avoid time-consuming review loops in audits, improve product safety and increase the efficiency of their processes.

Let's take our example of the new ISO 10993-7 again: with proactive monitoring and an efficient implementation process, this change would have been noticed early on and all necessary revisions can be implemented before the audit.

¹qtec

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