Building Technical Documentation Effectively

Product development is an all consuming process, taking considerable time and effort. An important activity associated with product development is the building of Technical Documentation to support your medical device for regulatory submissions. Technical Documentation is used describe a medical device and specify how a manufacturer has demonstrated that the product is safe and performs as they intend it to (in normal conditions).

Building Technical Documentation is a complex and detailed task. Some key factors, which feed into Technical Documentation, to consider in the early stages as part of product development are as follows:

–   Harmonised Standards (such as ISO 13485, ISO 14971, etc.):

• Review the harmonized standards list and consider which may apply to your medical device. Harmonised standards are an effective and common way of demonstrating performance and safety.

–   Risk Assessment:

• From the very beginning, appropriately documenting the risk assessment process according to the medical device risk assessment standard ISO 14971 can significantly assist in formalising risk documentation later on.

–   Clinical Evaluation:

• Consider regulatory requirements when developing clinical knowledge about your medical device.  Consider how best to record and evaluate findings from a regulatory perspective.

–   Product Assessment:

• Factor in regulatory requirements when deciding upon suitable product assessment activities for your medical device. Consider timing particularly when demonstrating product stability.

The information established during the product development phase, if gathered and documented in an effective way,  can greatly reduce the burden of building Technical Documentation down the track.

There are a number of guidance documents to assist in the development of regulatory compliant Technical Documentation, however the approach KD&A recommend is the Summary Technical Document (STED) as development by the now redundant Global Harmonisation Task Force (GHTF). This guidance document can be found here, and aims to ensure Technical Documentation complies with medical device regulatory requirements for a number of regions.

KD&A can assist your organization to plan and development Technical Documentation for regulatory purposes (including TGA Conformity Assessment, CE Marking, US FDA Clearance, etc.). KD&A use the STED format and work with you to develop high quality Technical Document to support your medical device regulatory submissions. If you are in the early stage of product development, KD&A can also assist you in developing a Regulatory Strategy for your medical device. Visit our Regulatory Strategy page for further detail.

Contact us with any questions, or for a personalised quotation.