Technical documentation (TD) is key to ensuring medical device safety, efficacy, and quality. As the cornerstone of regulatory compliance, it demands more than a one-time effort.

From navigating complex global regulatory requirements to maintaining consistent, up-to-date records throughout a product’s lifecycle, the challenges are immense – and they’re not going away.

Brought to you by our Head of Regulatory Bruno Gretler, our two-part whitepaper series on technical documentation for medical devices outlines the TD fundamentals and delves into its associated complexities, exploring regulatory frameworks, international considerations, and actionable solutions.

Part 1 highlights the technical documentation essentials, covering an outline of what TD encompasses, advice on how to structure your TD in the EU, and suggestions for navigating the requirements for global regulatory frameworks and balancing regional regulations with international standards.  

Download the free resource at the link below, and stay tuned for Part 2 of the series, where we’ll explore the challenges of maintaining your technical documentation and some practical advice for optimisation – to ultimately uncover how to transform your TD processes from a compliance burden into a powerful tool for success.

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To discover more about our Regulatory services, see here, and should you have a technical documentation related challenge, please do get in touch.