The technical documentation for medical devices bundles all the important documents for the manufacturer and end user relating to the product, the decisions made, the individual components and the entire development process. It is the key to a functional and safe medical device. From the first requirements and throughout the entire development of the medical device, comprehensive documentation ensures traceability and reliability right from the start. The associated increase in product safety means that detailed technical documentation is mandatory for manufacturers by the approval authorities and medical technology standards.
However, good technical documentation of medical devices goes beyond the mere obligation to comply with standards: in addition to the regulatory and normative benefits, the manufacturer itself also benefits from precise documentation of the relevant steps. On the one hand, it serves as reinsurance to avoid errors with problematic consequences – and also to minimize risks in the event of further development – and is also the hub for usability and risk management in order to ensure the health and safety of patients at all times.
Quality Features of Good Technical Documentation:
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It traces the development of the product from the idea to market surveillance
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It is clearly formulated and gets to the heart of the information required
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It is structured and sensibly linked
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It is easy to update and transferable to similar products
The high demands on technical documentation for medical devices have increased in recent years and yet it is not only worth creating it to ensure compliance with standards. This is because the fact that it is crucial to the success of medical devices often fades into the background.
Essential Contents of Technical Documentation for Medical Devices:
General Product Information
Specifications
Technical Specifications
Development of the Product
Risk Management
Our Service in the Field of Technical Documentation for Medical Devices:
We create documents that are required as part of the overall technical documentation – with and for our customers. We often work directly in the customer's quality management system and also check documents for completeness (review). We also advise on the content and structure of the documents so that the overall package makes sense and benefit from our best-practice examples. If required, we support the creation of templates that the customer can use for future products. We also offer solutions for setting up product platforms so that documents for different products do not have to be created from scratch each time. In doing so, we focus entirely on the customer's wishes: Whether start-ups that still have to overcome the normative hurdles or large companies that want to expand existing documents – we support you with technical documentation for medical devices.
Our interdisciplinary team is tried and tested thanks to our own medical device development and has a wealth of experience – from technical documentation to testing, we cover the entire product development cycle. The resulting open view of the relevant topics helps us to document all the important details in order to ensure optimum tracking in the product life cycle of medical devices.
Our Technical Documentation Services at a Glance:
We create comprehensive technical documentation and optimize existing documents for design input, design output, design verification and design validation as required. Listed below is an excerpt of our services:
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Technical reports (e.g. root cause analysis) and test protocols
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Technical drawings and parts lists (BOM)
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Tolerance analyses
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Traceability matrix
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FMEA and risk analyses
We use our wealth of experience to provide our customers with comprehensive advice and concepts, for example in the following areas:
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Checking existing documents for completeness
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Identifying optimization potential
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Advice on setting up platform documentation
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Setting up an FMEA including moderation
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Transfer of the content from the design verification to the Notified Body Opinion documentation
Thanks to our service, our customers can focus on their core tasks and receive a customized solution for professionally created technical documentation for their medical devices.
FAQ Technical Documentation
The technical documentation of medical devices is a compilation of all relevant documents that are created throughout the entire product life cycle. It not only pursues the goal of fulfilling the manufacturer's obligations to provide evidence to legal requirements and organizations – for medical devices in particular the MDR (Medical Device Regulation) and ISO 13485:2016 or the requirements of the FDA – but also contains documents that are made available to the customer, such as the operating instructions.
For us, the technical documentation for medical devices is not just a collection of documents that need to be created due to specifications, but a great opportunity to collect a company's knowledge and expertise and make it useful and accessible.
The manufacturers of medical devices must prepare the technical documentation in order to be able to submit it to the notified bodies. It is also used as a common thread during audits. However, it is also a guide to the product itself, enabling the entire history of the product's development to be recorded in a comprehensible manner and thus answering current and future questions about the product.
At invenio, we not only provide support with technical documentation, but also develop products in accordance with ISO 13485. Based on this experience, we are convinced that documents should not become a stumbling block in development, but should accompany and supplement it in order to achieve the goal of a safe and robust product.
The technical documentation for medical devices is very diverse and its content varies depending on the requirements of the country of approval. However, the core content includes general information about the product – for example, its purpose and intended use – the product specifications (e.g. parts list, design calculations), technical information about the product (e.g. design drawings, materials and biocompatibility) as well as specifications on the development and quality assurance of the product from production to use by the end customer. Another essential component is the documents that contain the risk management of the product and thus provide the basis for the safe manufacture and use of the product.
Due to this enormous diversity, the best documents for us are those that are linked to the rest of the technical documentation in a robust and comprehensible way and thus fit perfectly into their environment. In this way, the technical documentation becomes a structured collection of linked documents that can be reused as far as possible in the development of new products in the platform concept.
ISO 13485:2016 introduced the medical device file. This specifies the documents that the technical documentation of medical device types/groups must contain:
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General description of the product including intended use, labeling and instructions for use
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Product specification Specifications on the product life cycle up to and including distribution (production, packaging, storage, distribution)
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Specifications for the product life cycle through to distribution (production, packaging, storage)
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Procedure for measurement and monitoring
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Requirements for installation and maintenance
Not only these essential documents required by the standard, but also the entire technical documentation must be comprehensible and traceable even years after a product has been placed on the market. We therefore require that the documents we create can be reproduced at any time and by any person from the relevant readership.
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